NEWS

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NEWS

  1. 1. September 2001 Children's Oncology NEWSVol III, No 1, Summer 2002 The Quarterly Newsletter of the Children's Oncology Group Dedicated To Discovery Committed To Care Inside 2 Nursing Discipline Website Goes Live! 3 Informed Consent 4 Site Visit Presentations 5 CRA News 6 Foundation News 7 Gold Ribbon Days 8 Membership Updates 9 Recent Group Publications 10 Request for Papers 11 Meeting News 11 Leukemia Research Grant 14 Announcements 15 Spring 2002 Meeting Sponsors The Children's Oncology Group is a National Cancer Institute-supported clinical cooperative group From the Group Chair This has been an extremely busy and eventful two months for the Children’s Oncology Group, beginning with ourApril Group meeting in Jacksonville and concluding with our recent site visit, also in Jacksonville. Despite some challenges in arranging travel, and minor inconveniences experienced in accommodations, theApril Group meeting at theAdams Mark Hotel engendered more favorable comments than any previous COG meeting. The facilities provided adequate space for general sessions and committee meetings and the registration procedures and organization were extraordinary. In a large part this was due to the excellent leadership of Christine Bevins, COG’s meeting planner, and the able assistance of staff from the Operations Center in Arcadia and the Research Data Center in Gainesville. Unfortunately, Christine has left the full-time employ of COG, but has agreed to work with us on a contractual basis for planning future Group and committee meetings. This meeting gave us an excellent opportunity to evaluate a model format for a three-and-a-half to four-day schedule, which we intend to duplicate in the future. This time it was specifically extended for preparations and rehearsals for the site visit, but for the future, the general schedule will be followed and there will be two general sessions, one each on Thursday and Friday. I am suggesting the following sequence for reporting by the disease committees; Day 1: Bone Tumors, Soft Tissue Tumors, Retinoblastoma, Neuroblastoma, Rare Tumors, Hodgkin’s Disease; and Day 2:ALL, Myeloid Disease, Developmental Therapeutics, CNS Tumors, and Non-Hodgkin Lymphoma. However, I am open to feedback from the discipline chairs regarding their preferences in presenting. The response from the Group membership regarding these general sessions has been extremely favorable. I will be working with Mark Bernstein, Chair of the Scientific Chairs Committee, to establish a regular rotation of scientific symposia for general attendance to be sponsored by individual disease committees at each meeting. The symposia are not expected to prevent individual scientific committees from inviting guest presenters should their individual budgets and the Group travel budget permit. Note that our site visit has caused our travel budget to be quite limited for the remainder of this year. continued on page 12
  2. 2. Throughout the world, knowledge gained through experience, research and new technology has dramatically changed the practice of nursing, but the focus remains the client. Nurses caring for children with cancer have maintained that client focus as they set the standard for caring for children and adolescents with cancer who are being treated on COG clinical trials. Over the past 20 years, as the nursing discipline developed in pediatric clinical trials groups, we have seen spectacular growth in technology via the Internet and world wide web which provide a venue for communication and information-sharing. The importance of the web revolves around the ease with which it can be used, its increasingly universal availability, and the search capabilities for accessing information contained within its millions of pages. A vital role of nursing in COG centers on linking scientific and laboratory informa- tion related to childhood cancer treatment with the nurses who take care of children and teens with cancer in their own institu- tions. With that in mind, the Nursing Discipline section on the COG website is being completely re-designed to be user- friendly and information-rich. Our goal is to make it painless to access the Nursing Discipline website so that every nurse in every institution on every shift who cares for children on COG protocols is fully connected to the COG Nursing Discipline. To access the nursing discipline website (http://members.childrensoncologygroup.org/), you will need a “username” and password. If you do not have an individual password yet, an institutional password can be obtained from the Clinical Research Associate at your COG institution. Once on the members page, three easy clicks (Committees, Discipline, Nursing) lead to the Nursing Discipline section. The Nursing Discipline home page contains the mission and values state- ments of the COG Nursing Discipline, as well as a listing of the Nursing Steering Committee with direct links to their email addresses. From the Nursing Discipline home page you can access other informa- tion via the navigation tool bar on the left of the page. Included are links to the five nursing subcommittees: Administration, Clinical Practice, Clinical Trials, Education and Research. At the time of publication, the Clinical Practice,Administration and Education subcommittee pages have been designed, and the Clinical Trials and Research subcommittee pages are under development. Nursing subcommittee pages. The website provides access to a wealth of information about the nursing subcommittees and how to become involved with the COG Nursing Discipline. By clicking on any subcommittee link, visitors can view several pages of useful information about the activities of the subcommit tee. Each subcommittee page delin eates the objectives of that group and supplies a link to the chairperson. Reference materials, meeting minutes, project guidelines and concept proposal forms are also available. The Clinical Practice subcommittee page has links to three sections: clinical issues, pharmacology and late effects. Current projects for each section can be reviewed by clicking on the appropriate link. An e-mail forum for COG nurses interested in late effects issues is available through a simple subscription process. TheAdministration subcommittee page contains links to the Nursing Discipline administrative guidelines and important new member informa tion. Nursing Discipline Website Goes Live! The Education subcommittee page gives access to the various resources which have been developed by the subcommittee. It also contains up to date information on the nursing workshop to be held in Atlanta in Spring2003 From the Nursing Discipline home page, you can also access information on nursing membership and nursing meetings. Nursing membership. By clicking on “membership,” nurses can apply for individual membership in the COG. Any Registered Nurse associated with a COG institution is eligible to apply as an associate member of the COG Nursing Discipline . Afour part process is required for application, consisting of an individual application form, biographical sketch, conflict of interest form and form for recommen dation from the Principal Investigator. A demonstration application is pro vided to make the process easy to follow. Benefits of individual COG membership include: participation in COG Nursing Discipline subcommit tees, task forces, and project teams; voting privileges within the COG Nursing Discipline; and individual access to the COG website. Nursing meetings. The nursing meetings page provides minutes from past meetings and updates on future meetings. Visitors to the Nursing Discipline website will have ready access to a wealth of information from nurses participating in all areas of work of the Children’s Oncology Group. The launch date for the web page is June 10th . The Steering Committee of the COG Nursing Discipline encourages you to visit and enjoy! Please let us know your thoughts and suggestions about how we can continue to improve your nursing website for you. Lona Roll, RN, MSN, Casey Hooke, RN, MSN, Wendy Landier, RN, MSN, CPNP Nursing Discipline Committee Children’s Oncology News / Summer 2002 2
  3. 3. This article updates members of COG on the Project on Informed Consent (CCG- S9901), a multi-site, NCI-funded CCG legacy study aimed at describing and understanding informed consent processes in pediatric leukemia randomized trials. Its specific aims are to: 1) generate data that will inform scientific understanding of the process of informed consent for clinical trials in childhood cancer; 2) identify potentially vulnerable sub-groups who may benefit from targeted interventions to improve informed consent; 3) work together with a group of parents to identify barriers to informed decision-making, and recommend measures to improve the consent process; and, 4) describe similarities and differences in the consent process between pediatric and adult cancer patients. One hundred forty parents were recruited from six CCG institutions that routinely treat children with acute leukemia: Rainbow Babies & Children’s Hospital of University Hospitals of Cleveland in Cleveland, Ohio (n = 21); Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania (n = 42); Children’s Hospital Medical Center in Cincinnati, Ohio (n = 16); Children’s Hospital of LosAngeles in LosAngeles, California (n = 36); MD Anderson Cancer Center in Houston, Texas (n = 5); and Children’s National Medical Center in Washington, D.C (n = 20). Data collection took place from July 1, 1999 until December 31, 2001. Trained researchers observed and tape recorded the informed consent conference(s) (ICCs) that clinicians convened for the purposes of discussing treatment options including participation in a randomized clinical trial (RCT). Each taped conference was later coded using the Observer Checklist (OC), an instrument developed to code behaviors specific to clinical discussions related to cancer.1 Our version of the Observer Checklist includes codes for behaviors Informed Consent in the Children’s Oncology Group continued on page 4 Principal Investigator: Erick Kodish, MD, Director, Rainbow Center for Pediatric Ethics Children’s Oncology News / Summer 2002 3 relating to discussion of the disease, its treatment, and participation in a clinical trial. Parents were interviewed within 48 hours of their informed consent conference with their child’s clinician(s), and then interviewed again once they had made a decision about whether or not to participate in the RCT. To avoid conflicting responses from multiple family members, we limited our interviews to the parent or surrogate who was most active during the audiotaped informed consent discussions whenever possible. We designed the parent interviews, available in English and Spanish, to elicit information regarding parents’ understanding of the informed consent information as well as factors related to their decision to participate (or not) in the clinical trial for the treatment of their child’s leukemia. Follow up interviews were conducted over the telephone 6-8 months after diagnosis, and included items to assess long-term understanding of issues related to clinical trial participation. Our methodology provides an accurate and comprehensive description of what actually transpires during the informed consent process. Carefully collected data on parental understanding complements this descriptive data, allowing us to link disclosure and understanding for each case we have studied. Clinicians who participated in an audiotaped informed consent conference were asked to complete a questionnaire relating to the information that was given to parents/ patients and the clinician’s recommendations regarding treatment options. In addition to this case-specific questionnaire, clinicians at all six institutions were asked to fill out a general questionnaire about their attitudes toward informed consent.2 Results: One hundred forty of the 164 parents (85%) approached for consent to our study agreed to participate. Forty-four percent of these 140 parents were minority subjects, including 36 Latinos, 13African Americans, 6 Asians and 6 other minority subjects. The diagnoses of the children included 125 with acute lymphoblastic leukemia, 14 with acute myelogenous leukemia, and one with myelodysplastic syndrome. These children included 80 male and 60 female patients, with a mean age of 7.0 years (range 1-18). Eighty-four percent of the 140 parents in our study consented to participation in a randomized clinical trial for their child. The mean length of the observed ICC was 78 minutes (range 25-183), with 6.5 participants (range 2-15). The clinical trials offered to these families include CCG 1952(n=24),CCG1961(n=65),CCG1991 (n=36) and CCG 2961 (n=15). We observed presentation of the consent document during the ICC in 95% of cases, most frequently taking place at the end of the conference. An attending physician was most active during the ICC in 67% of cases, and a fellow was most active in 33%. A nurse was present in 47% of cases,3 and a clergy member attended only two of the 140 cases we studied. English was used in 113 ICCs, a Spanish translator in 26, and a Cantonese translator in 1 case. Most of the conferences (76%) we studied took place without the child-patient being present. Of the 33 cases in which the child was present during the ICC, 16 involved children younger than 8 years of age. Among the 17 ICCs that older children attended, the child’s participation in discussion of the RCT was quite limited.4 Our analysis of the Observer Checklist and parent interviews provides a wealth of
  4. 4. Children’s Oncology News / Summer 2002 4 Informed Consent in the Children’s Oncology Group - continued from page 3 information about how clinicians conduct informed consent conferences and how parents understand the information conveyed to them. Key findings include the observation of an explanation of randomization in 74% of cases, an explanation of the consent document in 73% of cases, and an explanation of treatment options outside of the clinical trial in 89% of the cases. The trial was described as voluntary in 94% of cases and the right to withdraw was discussed in 71% of cases. Despite extensive prompting during structured interviews, 46 of 140 parent interviews analyzed (33%) show no evidence that the parent was able to distinguish off-study treatment from study participation for their child with leukemia. Even more striking is the finding that 51% of the parents we interviewed did not understand that their child would be randomly assigned to treatment in the RCT. Thus, although clinicians generally do explain parental choice and randomization during the ICC, we have found that many parents do not comprehend these aspects of trial participation. Minority parents and those with low socioeconomic status, as measured by education and occupation, demonstrated the highest deficits in understanding. There were no significant differences in observed disclosure of choice about study participation or randomization between conferences involving majority versus minority parents, however significantly fewer minority parents understood choice (54%) and randomization (26%) when compared to majority parents, 77% of whom understood choice and 76% randomization. Significant differences in understanding were also found between those of high and low SES despite similar levels of disclosure. Another critical finding from this study is that the number of parent questions per ICC was positively associated with better comprehension of choice about the clinical trial (r=0.35, p<.0001 ) and understanding of randomization (r=0.34, p<.0001). The mean anti-log of parent questions for those cases in which parents comprehended choice about the clinical trial was 37, versus 18 for those who did not (t-test, p=.0002). Similarly, the mean anti-log of parent questions for those cases in which parents understood randomization was 41, versus 21 for those cases in which parents did not understand randomization (t-test, p<.0001). These findings suggest that understanding is related to parental participation as measured by question asking during the ICC. Future Plans: We are currently conducting Focus Groups with parents who participated in our study, and these will be completed early in June 2002. The focus groups are designed to elicit the views of parents regarding the informed consent process, including constructive suggestions for improving the process. The focus groups will be followed by the establishment of a Parent Advisory Group on Informed Consent (PAGIC), which will be comprised of parent representatives nominated from each of the focus groups. The PAGIC will assist the research team with interpretation of the data by providing their perspective as important stakeholders in the consent process. Our research has demonstrated specific gaps between information disclosed by clinicians and parental understanding of key informed consent issues. The next challenge is to utilize these findings to test rationally-designed interventions that may improve the quality of the informed consent process in childhood leukemia trials. To this end, we are planning a multi-site study to develop, test, and implement two data-based interventions: one directed at physicians and one directed at parents. We will be testing the effects of these interventions on key outcomes measures. A competitive renewal application has been submitted to NCI to request funding for this next stage of the work. In this way, COG can take the lead in proactive measures to insure the integrity of our clinical research. Efforts to bolster parental understanding, and augment parental participation during the ICC are likely to provide a significant improvement in informed consent. References: 1. Siminoff L, Fetting J. Factors affecting treatment decisions for a life-threatening illness. Soc Sci Med1991;32:813-18. 2. Simon C, Eder M, Raiz P, Zyzanski S, Pentz R, Kodish ED. Informed consent for pediatric leukemia research: clinician perspectives. Cancer 2001; 92:691-700. 3. Hinds PS, Gilger EA, Eder M, Kodish E. The nurse as witness in the research consent/assent process: an inherently problematic role, or an ethical obligation? Journal of Pediatric Oncology Nursing 2002; 19:35-40. 4. Olechnowicz J, Eder M, Simon C, Zyzanski S, Kodish E. Assent observed: children’s participation in leukemia treatment and research discussions. Pediatrics 2002;109:806-14. Site Visit Presentations Click on http:// members.childrensoncologygroup.org/ admin/sitevisitpresentations.asp to view slide presentations and posters from the recently completed Site Visit.
  5. 5. CRA News The CRA Research Sub-committee under Kim Nagel’s watchful eye has been very productive in the last few months. The following table outlines the posters that were presented at the last COG CRA Meeting as well as the status of our study proposals. Linda Churcher reported that there were a total of 17.5 contact hours of CRA Training at the recent meeting and according to the evaluations submitted, all presentations were well received. In fact respondents indicated that the lecture series topics were challenging, insightful and the speakers exceeded expectations with their knowledge and presentation skills. To all the speakers, a sincere thanks for volunteering your time to contribute to the education of our discipline. Remember that your input is essential in designing sessions that meet your ongoing needs. Linda welcomes your suggestions for future sessions. The site visit is now done - an interesting if tiring experience for all the Committee Chairs who had to give and defend presentations and posters. From my perspective it was a terrific opportunity to hear what all the committees plan for the next grant cycle. The site visitors asked some interesting questions about the CRA discipline and appeared impressed with our educational programs and contributions to the group. All the posters from the site visit will be brought to the next COG meeting for viewing. I think all CRAs will be very proud of our posters. (Posters are available for viewing on the members site at http://members.childrensoncologygroup.org/ adminsitevisitpresentations.asp ) One poster is titled Clinical Research Associates Facilitating Clinical Trials and depicts our responsibilities for data and regulatory requirements over the life of our studies. It also includes some interesting statistics. Did you know that there are currently 500 CRAs in COG and that currently there are about 45,000 patients in follow up. That would mean an average of 90 cases of follow up per CRA per year. I know, some days it feels like you’re doing all 45,000. The second poster, entitled Preparing Clinical Research Associates to Facilitate Clinical Trials, shows how our discipline goals to supply accurate, quality, timely data and to protect subjects through regulatory compliance are met through our education and training programs. In addition it reflects on how we improve quality and success of clinical trials and promote professional development through participation in COG. Have a great summer. Susan Devine, CCRP CRA Discipline Chair Children’s Oncology News / Summer 2002 5 Presented atApril 2002 COG Meeting COG Spring 2002 Group Meeting: CRA Poster Presentation Outline Table QualityAssurance Review Center (QARC) -Poster by F.Laurie The Value of In-service Teaching - Poster by S. Devine CRA, A Two-headed Monster??? - Poster by J. Hills & K. Nagel How a Protocol Becomes IRB Approved - Poster by E. Blatt Time and Effort Study Is the current method of per case reimbursement representative of real costs and conducive to maximum patient enrollment and if not, what would be an appropriate alternative? Does the audit preparation class at the continuing education session help an institutional CRA prepare for audit? New Study ProposalApril 2002 Survey Study Proposal October 2001, approved by COG, Pending Web Posting Survey Completed -Awaiting publication
  6. 6. The Foundation for the Children’s Oncology Group has elected Clarence Schmitz as the new Chairman of the Board. Schmitz is Managing Director of Golenberg Schmitz Capital Partners, LLC, in LosAngeles. He previously served as Treasurer of the Board of Trustees. In memory of his son C.T., who died of bone cancer at age 14, Schmitz recently sponsored the publication of the first Foundation wall calendar, along with C.T.’s mother, MaryAnn Schmitz. Serving as Vice-Chairs of the Board will be Dick and Mary Payne of Cleveland, Ohio. The new Treasurer of the Board will be John Walsh of Greens Farms, Connecticut. Foundation Seats New Chair Children’s Oncology News / Summer 2002 6 News Clarence Schmitz Shaving for (Cancer Research) Dollars This year, St. Baldrick’s has grown into the Foundation’s largest fundraising event, taking place in 36 locations, capturing national media attention including millions of viewers ofABC’s Good MorningAmerica and raising, to date, more than $675,000! Even our own Group Chair, Greg Reaman joined more than 300 shavees in the whimsical celebration in which men and women alike elect to shave their heads in solidarity with children undergoing cancer treatment. His sacrifice raised more than $13,000 in a single day. Jenny Halron, a ped-onc nurse at St. Vincent’s Hospital in Green Bay, Wisconsin was one of 20 female shavees in this year’s unprecedented fundraising event! Members of the Foundation’s Medical and Scientific Advisory Board are currently considering the ambitious challenge of raising $1 million in October to join the ranks of St. Baldrick’s bravest bald souls. In Green Bay, Wisconsin, several pediatric oncology doctors and nurses embraced St. Baldrick’s. One shavee was St. Vincent’s own pediatric oncology doctor, Jon Brandt. Post-event, he admitted, “it was obvious that [my patients and parents] were all appreciative and I sense a stronger relationship with them since the event. They hear me talk the talk, but seeing me walk the walk was irrefutable proof of my commitment to the cause”. If you would be interested in organizing a St. Baldrick’s celebration in your area next year, please contact Julie Halverson at Julie.Halverson@conquerkidscancer.org. According to Elva Blatt of Children’s Medical Center in Dayton, “it was easy!”
  7. 7. Children’s Oncology News / Summer 2002 7 Conquer Kids’ Cancer Gold Ribbon Days to shine in Washington, DC Program to be held September 25- 27, 2002 during Childhood Cancer Awareness Month Childhood cancer patients, survivors, parents, families, caregivers and others will meet in Washington, DC on September 25- 27, 2002 to Conquer Kids’ Cancer and raise awareness for cancer’s youngest patients and their families. This unique program provides an opportunity for all whose lives have been touched by the devastating diseases known collectively as “childhood cancer” to unite, raise awareness and actively support policies that would be of the greatest benefit to patients, survivors, families and caregivers. The program currently includes: · Legislative Workshop -An informational session to discuss timely public policies affecting children with cancer and preparations for meetings with Members of Congress and legislative staff on the following day. · Conquer Kids’ Cancer Gold Ribbon Rally on Capitol Hill - Childhood cancer patients, survivors, families, caregivers and Members of Congress will gather to highlight the importance of childhood cancer and to support improved policies to benefit children with cancer and their families. · Congressional Visits - Patients, survivors, parents, caregivers and others will visit Congressional offices. · Parent and Family Educational Program -Aday-long program devoted to providing updated information on childhood cancer research frontiers, new therapies, patient care considerations, childhood cancer registries and other important issues. The Washington DC program was developed by the Foundation for the Children’s Oncology Group in 2000. Several childhood cancer organizations, including the Children’s Oncology Group, are involved with the program as Collaborating Partners. September 2002 marks the second time that childhood cancer patients, survivors, families, caregivers, researchers and organizations will convene in the nation’s capitol for this program. The 2001 program was cancelled due to the September 11 terrorist attacks on America. More than 12,000 children and adolescents are diagnosed with cancer every year. Childhood cancer is the number one disease killer of children and adolescents in North America. More children die of cancer than of any other disease, including asthma, diabetes, cystic fibrosis, congenital anomalies and AIDS, combined. To register for the program, view updated information or learn about ways you can become involved, contact Lisa Parks, Director for Public Awareness at Lisa.Parks@ConquerKidscancer.org or visit the Foundation’s website, www.ConquerKidsCancer.org and click on the gold ribbon.
  8. 8. Membership Updates The following Institutional Membership Applications were approved: Beth Israel Medical Center NewYork, NewYork Dr. JeffreyAllen Winthrop University Hospital Mineloa, NewYork Dr. MarkWeinblatt Children’s Healthcare ofAtlanta/Emory University Atlanta, Georgia Dr. Stephen J. Lauer Merge of the Children’s Healthcare of Atlanta, Scottish Rite and the Children’s Healthcare ofAtlanta, Egleston (Emory) approved. The following PI changes were approved: Maine Children’s Cancer Program Scarborough, Maine Dr. Molly Schwenn replaced Dr. Craig Hurwitz as PI. St. Joseph’s Children’s Hospital Paterson, New Jersey Dr. MaryAnn Bonilla replaced Dr. James Garvin as PI. Toledo Children’s Hospital Toledo, Ohio Dr. Richard Shore replaced Dr. Dagmar Stein as PI. Tulane University Medical Center New Orleans, Louisiana Dr. Marshall Schorin replaced Dr. Charles Scher as PI. Children’s Oncology News / Summer 2002 8 Abstracts Due Please note that abstracts are now due for the next EORTC-NCI-AACR “Molecular Targets and Cancer Therapeutics” Conference, taking place in Frankfurt, Germany, November 19-22, 2002. Please send any abstracts using agents provided by CTEP to the RegulatoryAffairs Branch for forwarding to the Industry Collaborator as soon as possible to: Sherry S.Ansher, Ph.D. Coordinator, Research & DevelopmentAgreements RegulatoryAffairs Branch CTEP/DCTD Phone # 301-496-7912 Fax#301-402-1584 Email:Anshers@ctep.nci.nih.gov The following Provisional Full Member PI changes were approved: Michigan State University East Lansing, Michigan Dr. Renuka Gera replaced Dr. Roshni Kulkarni as PI. Saint Barnabas Medical Center Livingston, New Jersey Dr. Brenda Sison replaced Dr. MaryAnn Bonilla as PI. The following Provisional Full Member PI change was approved with a contingency: Atlantic Health System Summit, New Jersey Dr. Michelle Miller replaced Dr. Ronald Kline as PI. Employment Opportunity Pediatric Bone Marrow Transplant Seeking BE/BC pediatric hematologist-oncologist with clinical and research interest in bone marrow transplantation to expand growing pediatric transplant program in setting of new children’s hospital and comprehen- sive cancer center. Interest in adult BMT welcome but not required. Assistant professors with several years experience, associate, and full professors considered. Endowed chair may be available for qualified individual. Call 919-966-0590 for questions. Forward CV to Julie Blatt, M.D. Division of Pediatric Hematology-Oncology Dept of Pediatrics Macnider 418 CB #7220 University of North Carolina School of Medicine ChapelHill,NC27599.
  9. 9. Dinndorf P,Krailo MD,Liu-Mares W,Frierdich S,Sondel PM,Reaman GH. Phase I trial of anti-B4-blocked ricin in pediatric patients with leukemia and lymphoma.JImmunother24(6):511-516, 2002. Furman WL,Stewart CF,Kirstein MN,Kepner JL,Bernstein ML,Kung F,Vietti TJ,Steuber CP,Becton D,Baruchel A,Pratt CB. Protracted intermittent schecule of topotecan in children with refractory acute leukemia: a pediatric oncology group study J Clin Oncol 20(6)1617-1624,2002. Heerema NA,Sather HN,Sensel MG,La M,Hutchinson R,Nachman JB,Reaman GH,Lange BJ,Steinherz PG,Bostrom BC,Gaynon PS,Uckun FM.Abnormalities of chromosome bands 15q13-15 in childhood acute lymphoblastic leukemia Cancer94(4):1102-1110,2002. Lange BJ,Bostrom BC,Cherlow JM,Sensel MG,La M,Rackoff W,Heerema NA,Wimmer RS,Trigg ME,Sather HN. Double-delayed intensification improves event-free survival for children with intermediate-risk acute lymphoblastic leukemia: a report from the Children’s Cancer Group. Blood 99(3):825-833, 2002. Lones MA,Perkins SL,Sposto R,Tedeschi N,Kadin ME,Kjeldsberg CR,Wilson JF,Zwick DL,Cairo MS. Non-Hodgkin’s lymphoma arising in bone in children and adolescents is associated with an excellent outcome:ACCG report. J Clin Oncol20(9):2293-2301,2002. Shu XO,Han D,Severson RK,Chen Z,Neglia JP,Reaman GH,Buckley JD,Robison LL. Birth characteristics, maternal reproductive history, hormone use during pregnancy, and risk of childhood acute lymphocytic leukemia by immunophenotype. Cancer Causes Control13(1)15-25,2002. Recent Group Publications: Phase I Wells RJ,Reid JM,Ames MM,Mares WL,Krailo MD,Seibel NL,Mosher R,Reaman GH,Wiersma S.APhase I trial of cisplatin and topotecan in children with recurrent solid tumors: Children’s Cancer Group study 0942. J Peditr Hematol Oncol 24(2):89-93,2002. Leukemia/Lymphoma Children’s Oncology News / Summer 2002 9 Neuroblastoma/CNS Eberhart CG,Kepner JL,Goldthwaite P,Kun L,Duffner PK,Friedman HS,Strother D,Burger P. Histopathologic grading of medulloblastomas.APediatric Oncology Group study. Cancer 94(2):552-560, 2002. Kletzel M,Katzenstein HM,Haut PR,Yu AL,Morgan E,Reynolds M,Geissler G,Marymount MH,Liu D,Kalapurakal JA,Shore RM,Bardo DM,Schmoldt J,RademakerAW,Cohn SL. Treatment of high-risk neuroblastoma with triple- tandem high-dose therapy and stem-cell rescue: Results of the Chicago Pilot II study J Clin Oncol 20(9):2284-2292, 2002. Merchant TE. Current management of childhood ependymoma Oncology 16(5):629-642,2002. Pollack IF,Finkelstein SD,Woods J,Burnham J,Holmes E,Hamilton RL,Yates AJ,Boyett JM,Finlay JL,Sposto R. Expression of p53 and prognosis in children with malignant gliomas N Engl J Med346(6):420-427,2002. Woods GM,Barnard DR,Alonzo TA,Buckley JD,Kobrinsky N,Arthur DC,Sanders J,Neudorf S,Gold S,Lange BJ. Prospective study of 90 children requiring treatment for jeuvenile myelomonocytic leukemia or myelodysplastic syndrome:A report from the Children’s Cancer Group J ClinOncol20(2):434-440,2002. Wilms Tumor Abu-GhoshAM,Krailo MD,Goldman S,Slack RS,DavenportV,Morris E,Laver J,Reaman GH,Cairo MS. Ifosfamide, carboplatin, and etoposide in children with poor-risk relapsed Wilms’tumor: a Children’s Cancer Group reportAnn Oncol 13:460-469,2002. Raney RB,Meza J,Anderson JR,Fryer CJ,Donaldson SS,Breneman JC,Fitzgerald TJ,Gehan EE,Michalski J,Ortega JA,Qualman SJ,Sandler E,Wharam MD,Wiener ES,Maurer H,Crist WM. Treatment of Children and Adolescents with Localized Parameningeal Sarcoma: Experience of the Intergroup Rhabdomyosarcoma Study Group Protocols IRS-II through-IV, 1978-1997. Med Pediatr Oncol 38:22-32, 2002. Rhabdomyosarcoma Green DM,Peabody EM,Nan B,Peterson S,Kalapurakal JA,Breslow NE. Pregnancy outcome after treatment for Wilms tumor: Areport from the National Wilms Tumor Study Group J Clin Oncol 20(10):2506- 2513,2002. Other Bone GoorinA,Harris MB,Bernstein ML,Ferguson WS,Devidas M,Siegal GP,Gebhardt MC,Schwartz C,Link MP,Grier HE. Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma:APediatric Oncology Group trial. J Clin Oncol 20(2):426-433,2002. Sposto R. Cure model analysis in cancer: An application to data from the Children’s Cancer Group. Stat Med 21:293-312, 2002.
  10. 10. Children’s Oncology News / Summer 2002 10
  11. 11. CHILDREN’S ONCOLOGY GROUP UPCOMING MEETINGS Dates Meeting Location 10/01 – 10/02/02 DSMC Meeting Denver, CO (Tuesday – Wednesday) 10/22-10/27/02 Fall Group Meeting St. Louis, MO (Tuesday – Sunday) 3/25 – 3/30/03 Spring Group Meeting Atlanta, GA (Tuesday – Sunday) 3/24 – 3/29/03 COG Nurses Conference Atlanta, GA (Monday – Saturday) 11/4 – 11/9/03 Fall Group Meeting Dallas, TX (Tuesday – Sunday) For more information on COG Meetings, please contact: Christine Bevins at 626-447-0064 X118 or email her at cbevins@childrensoncologygroup.org Meeting News The COG Fall Group Meeting will be held October 22 - 27, 2002 in St. Louis, Missouri. Hotel andAgenda information will be available approximately two months prior to the meeting. Email notification will be sent out to all members when online registration, agenda and travel information are available on the member web site. We look forward to seeing you there. Children’s Oncology News / Summer 2002 11 Leukemia Research Grant The Ronald McDonald House Charities of Southern California and Couples Against Leukemia are again offering an annual research grant to support research in the field of adult and pediatric leukemia. The purpose of this grant is to support young investigators at the postdoctoral level (MD or Ph.D.) at West Coast institutions who have the clear potential to compete successfully for eventual federal funding. Recent awards have gone to investigators from the University of California in San Francisco and the University of Washington in Seattle. Interested individuals should submit an application before October 1, 2002 to: Paul Gaynon, MD John Groffen, Ph.D. Professors of Pediatrics Division of Hematology/Oncology Childrens Hospital Los Angeles 4650 Sunset Blvd., LosAngeles, CA90027
  12. 12. 4. Raise $8 million by the end of 2002 5. Fully constitute the Board of Trustees by the end of 2003 6. Determine a strategic direction to increase public awareness about the Foundation and COG bymid-2003 7. Adoption of a five-year fundraising goal of $25 million per year by 2007 and a ten-year goal of $50 million per year by 2112 8. Perfect collaborative efforts between the Foundation and COG membership and develop standards to measure such effective collaboration 9. Expand private foundation support and increase corporate support to cause related marketing and sponsorships 10. Determine optimal methods by which international donors could participate in the philanthropic activities of the Foundation 11. Maintain the current organizational structure of the Foundation and evaluate liability “firewalls” between the Foundation and COG and develop an indemnification agreement between the Foundation and COG 12. Maintain the grantee organization inArcadia, located with the Group Operations Center, and continue to operate public awareness and fundraising activities on the West Coast from the Arcadia location From the Group Chair - continued from page 1 13. Establish a corporate Foundation headquarters in the Washington, DC area and consider locating COG Chair’s Office at that site. This would not require that the new President take up residence in Washington, DC. 14. Consider other strategic locations to develop offices for development/public awareness activities 15. Use a D/B/A (Doing Business As) or consider a change of name for the Foundation for purposes of fundraising and awareness activities based on professional market-testing analysis and advice. Children’s Oncology News / Summer 2002 12 I remain committed to schedule our Group meetings at hub airport cities to facilitate air travel to the extent possible, and to conclude sessions for most attendees so they are not required an overnight stay on Saturday. Our next three meetings, beginning this fall, are planned for St. Louis, Atlanta, and Dallas. Also, we are investigating East Coast and West Coast hub cities for subsequent meetings. As reported at the Group meeting, the COG Foundation had an extremely successful strategic planning retreat that involved numerous COG members and members of the Medical and Scientific Advisory Board. Several task forces (Mission, Vision and Values, Organization, Fundraising, and Board Member Recruitment) had worked before the retreat and met individually at the retreat in Washington, DC, with a charge to make specific recommendations in each of those areas to the Long-Range Planning Committee of the Board of Trustees. The strategic planning process was very ably led by Oncology Solutions, Dunc Pruett, and David Fulcher, principals. The recommendations of the various task forces to the Long-Range Planning Committee were then formulated as specific resolutions for vote to the Board of Trustees. Highlighted resolutions include: 1. Adoption of a mission statement: The mission of the Foundation is to raise funds for conquering childhood cancers. These funds support the work of the Children’s Oncology Group, the leading organization of doctors and scientists dedicated to discovery and compassionate cures. 2. Election of a new Chair of the Board of Trustees 3. Recruitment of a new President by the end of this year continued on page 13 These resolutions were unanimously passed by the Board of Trustees. Progress to date has included identification of eight highly qualified candidates for the position of Foundation President. These were discussed by conference call, and four were selected to be interviewed by the Search Committee in Washington, DC on June 19. The Search Committee includes Drs. Michael Harris, Robert Castleberry, and myself from COG and is co-chaired by Ms. Mary Payne and Mr. Chuck Greener, and includes Mr. Clarence Schmitz.At this meeting I made clear my intentions to step down as Chair of the Board of Trustees, having brought the Board through a very critical transition period and having promised COG membership that I would hold this position only long enough to ensure that there was sufficient stability for the Foundation to continue serving as the Group’s grantee organization. This strategic planning process validated the commitment of the Trustees and the Foundation to support the COG. Their energy and enthusiasm were palpable. We are extremely fortunate that Mr. Clarence Schmitz from LosAngeles was elected Chair of the Board of Trustees and this
  13. 13. Children’s Oncology News / Summer 2002 13 degree of discipline integration into Group science and clinical trials and specific examples, confusion regarding centralized tissue procurement and banking at the Biopathology Center compared with that performed by individual disease committees and potential areas of conflict, justification for additionalALL reference laboratories, and concerns that there were no formal presentations by the Bioethics Committee or the Patient Advocacy Committee, the importance of both of which was well described in the grant application. Unofficial feedback from several of our international reviewers revealed how stunned they were as a group that there could have ever been such cooperation between CCG and POG. We should have a preliminary review report in approximately two weeks and I will share that with you. The presentation slides are available for your viewing on the COG website, and the posters presented by the discipline committees and others will be presented again at the Fall meeting. At our last COG meeting, the Executive Committee approved my recommendation that COG assume the position formerly held by POG in National Coalition of Cooperative Groups, which is a not-for- profit foundation incorporated in 1997. The mission of the coalition is to improve survival and quality of life of cancer patients through increased clinical trial participation and a goal of doubling participation in cancer clinical trials by 2005. The coalition already has begun some successful media awareness campaigns and is planning viewpoint discussions with Coalition board members (cooperative group chairs) to raise the visibility of cooperative groups in clinical trials. For many reasons, notably our adolescent and young adult initiative and the fact that the Coalition may well become instrumental in managing industry-sponsored clinical trials supported by CTEP, it is important to assure appropriate pediatric representation in the Coalition. Several policies are in development and will be shared with you soon, pending formal review and adoption by the Executive Committee. They pertain to exchange of scientific information and provision of patient accrual credit to transplant institutions for clinical trials that incorporate stem cell transplantation. The latter issue has been a matter of significant concern since our unification. Attempting to provide retrospective credit, or attempting to deal with current studies, given the current limitations of our remote data entry system and Research Data Center, make such consideration unfeasible. The plan is to provide a separate RDE screen for transplant data collection which would also provide data to the Operations Center for reimbursement credit . All protocol- specified data related to donor procurement, processing, transplant, and post-transplant follow-up would be clearly designated in the protocol and be the responsibility of the transplant center that is claiming the credit. The process would be monitored, like all other study compliance and data submission expectations, by the Institutional Performance Monitoring Committee. From the Group Chair - continued from page 12 good fortune was further magnified by the election of Richard and Mary Payne as co-vice chairs and Mr. John Walsh as Treasurer and Chair of the Finance and Audit Committee. My nearly 12 years of experience on this board and that of its predecessor Foundation assure me that this is a new beginning for the Foundation for COG as it has been for us a new beginning in COG. Foundation office space has been leased in a very convenient, high-profile location in the center of Bethesda, at the intersection of Wisconsin Avenue and East-West Highway, approximately ¾ of a mile from the NIH campus. Location of certain Foundation functions and occupation of this space will occur in late summer. Speaking of new beginnings, as you know, our first COG site visit was held June 5-7. I cannot begin to describe my sense of pride in having the honor to lead this effort, which epitomized the three C’s of COG: collaboration, cooperation, and collegiality.All presentations were executed expertly and questions were handled adeptly. The spirit of collaboration that went into presentation preparation, rehearsal, revision, revision, revision was really nothing short of extraordinary. This was an amazing group effort that provided convincing evidence to me and to our reviewer colleagues that the merger of our four legacy groups truly has been a success. Coordinating the site visit was such an enormous undertaking for the NCI, with 48 reviewers and 20 European ad hoc reviewers, several of whom were unable attend at the last minute, has convinced the Grants Review Section that future competitive renewals for all of the cooperative groups may be smaller in scale, with reverse site visits directly by Subcommittee H. This was presented at the Group Chair’s meeting just before our site visit and was uniformly embraced by all cooperative group chairs. I certainly would have embraced the recommendation myself had it been made a year ago! Several areas of concern were raised during the executive session with the review team, which were addressed satisfactorily. They included
  14. 14. Ronald Leslie Chard Jr., MD, age 71, passed away quietly on the morning of May 14, 2002 in the presence of his loving wife FrancesAllan Chard after a courageous 2-year battle with cancer. Ron was born September 23rd , 1930 to Ronald Leslie Chard Sr. and Della Mae (Crumpacker) Chard in Pomeroy, WA. He attended Pomeroy schools where he excelled at sports. On graduation from Pomeroy High School, he attended Washington State University, participating on the boxing team and receiving a degree in Physical Education. From 1952-1953 he attended Duke University in North Carolina and received a degree in Physical Therapy. Ron was inducted into the USArmy in 1954 and served in Germany, returning in 1956. After working briefly as a Physical Therapist in Colorado, he attended the University of Washington Medical School, graduating in 1963. He completed a pediatric internship and residency at Children’s Hospital and University of Washington Medical Center. At the urging of Jack Hartmann, MD, Ron did a Fellowship in Hematology/Oncology at Children’s Hospital and quickly became the dominant physician in the program. He was Clinical Director of Hematology and Oncology at Children’s from 1969 to 1992. In 1970, Ron became a Principle Investigator with the Children’s Cancer Group, a national research organization, and served as Associate Chairman for Leukemia Studies, as well as being on the Executive Committee and Vice Chairman during the course of his tenure with the organization. He authored over 40 publications about childhood cancer and treatment and trained 80 pediatric hematologist/oncologists who are currently practicing within the US and throughout the world. Ron will be most fondly remembered for the compassionate bedside care that he provided for the families he treated and as a role model to young doctors of how it should be done. In Ron’s rare spare time he was an avid golfer. He was a lifelong sports fanatic, and much to the chagrin of his UW colleagues, a Cougar fan to the core. His parents, Ronald and Della, and his younger brother, James Chard, preceded him in death. Ron is survived by his wife, Frances, his 5 children, Holly Burton (John), Teresa Courtney (Herb), Cassandra Aspinall (Robert), Nicholas Chard, Joseph Chard (LisaJo), and their mother, Carolyn (Hulseman) Chard. He also leaves 9 grandchildren; Danny, Ian, Peter, Madeline, Tony, Tim, Simon,Ashlee and Creed. In addition, Ron will be missed dearly by all of his colleagues at Children’s Hospital, the University of Washington and Fred Hutchinson Cancer research center, as well as the many patients and families that he treated over his 32 year career. The family would like to express thanks to the staffs of University of Washington Medical Center, Seattle Cancer Care Alliance, and a special thanks to Jonathan Drackman, MD, who was of particular comfort to Ron and Fran during Ron’s long illness. Many thanks to the staff at Evergreen Hospice. Ronald Leslie Chard, MD 1930 - 2002 Announcements Children’s Oncology News / Summer 2002 14
  15. 15. Children’s Oncology News / Summer 2002 15
  16. 16. Our Mission: To cure and prevent childhood and adolescent cancer through scientific discovery and compassionate care Children's Oncology Group Children's Oncology News COG Chair Gregory Reaman, MD Associate Chairs Les Robison, PhD Michael Link, MD William Woods, MD Timothy Triche, MD Research Data Center Director James Kepner, PhD Office Locations COG Operations Center P.O. Box 60012 Arcadia, CA 91066-6012 (626) 447-0064 COG Research Data Center 104 N. Main St. #600 Gainesville, FL 32601 (352) 392-5198 Editor Sam Yoo Scientific Editor Shaun Mason Contributing Authors Lona Roll, RN, MSN Casey Hooke, RN, MSN Wendy Landier, RN, MSN, CPNP Erick Kodish, MD Susan Devine, CCRP Children’s Oncology News is published quarterly. Please send article ideas and any other suggestions to Sam Yoo at syoo@childrensoncologygroup.org COG Vice Chair Robert Castleberry, MD Executive Officer Anita Khayat, PhD, MBA Group Statician Mark Krailo, PhD

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