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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026312 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy, interleukin-2, and sargramostim following stem cell transplantation in treating neuroblastoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without monoclonal antibody, interleukin-2, and sargramostim following stem cell transplantation in treating patients who have neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Biological: aldesleukin Biological: monoclonal antibody Ch14.18 Biological: sargramostim Drug: isotretinoin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Randomized Study Of Chimeric Antibody 14.18 (CH14.18) In High Risk Neuroblastoma Following Myeloablative Therapy And Autologous Stem Cell Rescue |
| Estimated Enrollment: | 423 |
| Study Start Date: | October 2001 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I (closed to accrual as of 4/16/2009): Active Comparator
Patients receive oral isotretinoin twice daily for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: isotretinoin
Given orally
|
|
Arm II: Experimental
Patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and monoclonal antibody Ch14.18 IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral isotretinoin as in arm I beginning on day 11 of immunotherapy.
|
Biological: aldesleukin
Given IV
Biological: monoclonal antibody Ch14.18
Given IV
Biological: sargramostim
Given subcutaneously or IV
Drug: isotretinoin
Given orally
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma
Meets all of the following criteria:
Completed frontline therapies, examples of such therapy includes:
Tandem transplant patients are eligible
Must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Creatinine adjusted according to age as follows:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 156 Study Locations| Study Chair: | Alice L. Yu, MD, PhD | University of California, San Diego |
More Information
| Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
| Study ID Numbers: | CDR0000069018, COG-ANBL0032, COG-P9842 |
| Study First Received: | November 9, 2001 |
| Last Updated: | November 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00026312 History of Changes |
| Health Authority: | Unspecified |
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regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma localized resectable neuroblastoma localized unresectable neuroblastoma |
|
Anti-Infective Agents Neuroectodermal Tumors, Primitive Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Neuroblastoma Antibodies, Monoclonal Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Isotretinoin Dermatologic Agents |
Immunoglobulins Neoplasms by Histologic Type Anti-HIV Agents Antiviral Agents Pharmacologic Actions Neuroectodermal Tumors Antibodies Neoplasms Aldesleukin Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |