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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002458 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating children with metastatic neuroblastoma in second remission.
Condition | Intervention | Phase |
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Neuroblastoma |
Biological: monoclonal antibody 3F8 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Adjuvant Therapy With Antiganglioside GD2-Specific Mouse Monoclonal Antibody 3F8 for Metastatic Neuroblastoma in Second Remission |
Study Start Date: | November 1987 |
OBJECTIVES: I. Evaluate the efficacy of ganglioside GD2-specific monoclonal antibody 3F8 as adjuvant therapy in patients with Stage IV neuroblastoma in second remission.
OUTLINE: Biological Response Modifier Therapy. Antiganglioside GD2-specific Monoclonal Antibody 3F8, MOAB 3F8.
PROJECTED ACCRUAL: A maximum of 20 patients will be entered.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed, Stage IV neuroblastoma in second or subsequent complete remission, defined by the complete disappearance of all evidence of tumor on the following: Physical examination Second-look surgery Bone scan Bone marrow aspiration and biopsy Chest x-ray CT MIBG Urinary catecholamines If marrow is infiltrated by tumor, complete elimination of tumor cells from the marrow compartment must be demonstrated by histology and immunofluorescence (based on simultaneous bone marrow aspiration and biopsy samples from at least 4 separate sites)
PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Life expectancy: Greater than 12 weeks Hematopoietic: Grade 4 cytopenias allowed Grade 3 marrow hypoplasia allowed Hepatic: Not specified Renal: No renal dysfunction worse than grade 3 Cardiovascular: No cardiac dysfunction worse than grade 2 Pulmonary: No pulmonary dysfunction worse than grade 2 Other: No neurologic dysfunction worse than grade 2 Hearing deficit allowed
PRIOR CONCURRENT THERAPY: Prior murine antibody therapy allowed provided circulating HAMA titer is less than 1,000 U/mL serum by ELISA
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Nai-Kong V. Cheung, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000075103, MSKCC-87118, NCI-V88-0357 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002458 History of Changes |
Health Authority: | United States: Federal Government |
disseminated neuroblastoma recurrent neuroblastoma |
Neuroectodermal Tumors, Primitive Immunologic Factors Adjuvants, Immunologic Neuroblastoma Recurrence Antibodies, Monoclonal Neuroectodermal Tumors |
Antibodies Neoplasms, Germ Cell and Embryonal Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial Immunoglobulins |
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Neoplasms, Nerve Tissue Pharmacologic Actions Neuroblastoma Antibodies, Monoclonal |
Neuroectodermal Tumors Neoplasms Antibodies Neoplasms, Germ Cell and Embryonal Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |