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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: | NCT00002634 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. 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 combining chemotherapy, radiation therapy, immunotherapy, and bone marrow transplantation in treating patients with neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Biological: filgrastim Biological: monoclonal antibody 3F8 Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: mesna Drug: perfosfamide Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy Radiation: radioisotope therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | N7: EVALUATION OF MAXIMAL CHEMOTHERAPY DOSE INTENSITY PLUS MONOCLONAL ANTIBODY 3F8 IN THE TREATMENT OF NEUROBLASTOMA |
Estimated Enrollment: | 45 |
Study Start Date: | February 1995 |
OBJECTIVES: I. Improve the complete remission rate and progression-free survival and reduce the relapse rate of patients with poor-risk neuroblastoma using intensive multimodality therapy: cyclophosphamide/doxorubicin/vincristine and cisplatin/etoposide, external-beam radiotherapy, and surgery (when feasible), followed by radioimmunotherapy with iodine I 131 labeled monoclonal antibody 3F8 followed by autologous bone marrow transplant and immunotherapy with unlabeled 3F8. II. Identify biologic and clinical prognostic factors that may guide future modifications in treatment approaches for this malignancy.
OUTLINE: Patients are stratified by prior therapy (yes vs no). Patients undergo surgery either at diagnosis or after at least 4 courses of chemotherapy, then possibly again after completion of chemotherapy. Patients receive cyclophosphamide IV over 6 hours on days 1-2, and doxorubicin IV and vincristine IV over 72 hours on days 1-3 for courses 1, 2, 4, and 6. Cisplatin IV over 1 hour on days 1-4 and vincristine IV over 2 hours on days 1-3 are administered as courses 3, 5, and 7. Courses are administered every 16-21 days. Autologous bone marrow is collected after 3 courses of chemotherapy providing marrow is negative for tumor cells. Patients undergo radiotherapy after the completion of chemotherapy. Radiotherapy is administered twice a day for 7 days. Patients then receive iodine I 131 labeled monoclonal antibody 3F8 (MOAB 3F8) on day -5 and again on days 1-5. Autologous bone marrow is reinfused on day 5 and filgrastim (G-CSF) is administered IV or subcutaneously beginning day 6. Patients who do not develop HAMA or an allergy to mouse proteins receive unlabeled MOAB 3F8 IV over 1.5 hours, 5 days a week for 2 weeks. Treatment repeats every 1-2 months for up to 4 courses. Patients are followed every month for 2 years, every 3 months for 1 year, then annually thereafter.
PROJECTED ACCRUAL: Up to 45 newly diagnosed patients will be accrued for this study within 5 years.
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Neuroblastoma diagnosed in accordance with the International Neuroblastoma Staging system: Histologic confirmation at MSKCC OR Elevated urinary catecholamines plus tumor cells/clumps in bone marrow Stage IV or Stage II/III with more than 10 copies of N-myc proto-oncogene per tumor cell
PATIENT CHARACTERISTICS: See General Eligibility Criteria
PRIOR CONCURRENT THERAPY: Prior therapy allowed -Patient Characteristics-- Age: Over 1 year at diagnosis Performance status: Not specified Hematopoietic: Absolute neutrophil count at least 500/mm3 (except for cases of bone marrow infiltration by tumor) Platelet count at least 100,000/mm3 (except for cases of bone marrow infiltration by tumor) Hepatic: Not specified Renal: Not specified Other: No history of allergy to mouse proteins Human antimouse antibodies (HAMA) less than 1,000 U/ml (with prior exposure to murine antibodies)
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: | CDR0000064084, MSKCC-94011A1, MSKCC-FDR001041, NCI-V95-0622 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002634 History of Changes |
Health Authority: | United States: Federal Government |
localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma recurrent neuroblastoma localized unresectable neuroblastoma |
Neuroectodermal Tumors, Primitive Immunologic Factors Cyclophosphamide Etoposide phosphate Neuroblastoma Antibodies, Monoclonal Anti-Bacterial Agents Cisplatin Cobalt Neoplasms, Germ Cell and Embryonal Neuroepithelioma Etoposide Alkylating Agents Immunoglobulins |
Vincristine Antimitotic Agents Immunosuppressive Agents Doxorubicin Recurrence Neuroectodermal Tumors Antibodies Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Mesna Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neuroblastoma Antibodies, Monoclonal Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Mitosis Modulators |
Vincristine Antimitotic Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Antibodies Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Antineoplastic Agents, Phytogenic Neuroectodermal Tumors, Primitive, Peripheral |