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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002560 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.
Condition | Intervention | Phase |
Neuroblastoma |
Drug: monoclonal antibody 3F8 Drug: sargramostim |
Phase II |
MedlinePlus related topics: | Cancer Neuroblastoma |
ChemIDplus related topics: | Sargramostim Granulocyte-macrophage colony-stimulating factor |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA |
Estimated Enrollment: | 40 |
Study Start Date: | February 1994 |
OBJECTIVES:
OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.
Ages Eligible for Study: | 2 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Neuroblastoma diagnosed by INSS criteria, i.e., either:
Relapsed disease with poor long-term prognosis as indicated by at least one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematologic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | |||||
New York, New York, United States, 10021 |
Memorial Sloan-Kettering Cancer Center |
Study Chair: | Brian H. Kushner, MD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000063466, MSKCC-94018, NCI-V94-0416 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002560 |
Health Authority: | United States: Federal Government |
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