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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450827 |
RATIONALE: Monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8 and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of neuroblastoma by blocking blood flow to the tumor. Giving iodine I 131 monoclonal antibody 3F8 together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 monoclonal antibody 3F8 when given together with bevacizumab in treating patients with relapsed or refractory neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: bevacizumab Drug: filgrastim Drug: iodine I 131 monoclonal antibody 3F8 Procedure: autologous hematopoietic stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Combination of Targeted I -3F8-Mediated Radioimmunotherapy and Bevacizumab in Patients With Relapsed or Refractory Neuroblastoma: A Phase I Study |
Estimated Enrollment: | 24 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody 3F8 (^131I-3F8).
Patients receive ^131I-3F8 IV over 20-30 minutes on day 0 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 courses. Patients whose blood counts do not recover and whose human antimouse antibody (HAMA) titer < 1,000 U/mL after course 1 receive one dose of ^131I-3F8 alone followed by autologous stem cell rescue (ASCR) and filgrastim (G-CSF). Patients whose blood counts do not recover and whose HAMA titer ≥ 1,000 U/mL after course 1 undergo ASCR followed by G-CSF. Patients whose blood counts recover and whose HAMA titer < 1,000 U/mL after course 1 receive 3 more courses of ^131I-3F8 and bevacizumab in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of ^131I-3F8 and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 3-4 weeks and then every 3-6 months thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma meeting 1 of the following criteria:
Must meet ≥ 1 of the following criteria:
Autologous hematopoietic stem cell product cryopreserved and available for reinfusion after study treatment
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Shakeel Modak, MD 212-639-7623 modaks@mskcc.org |
Study Chair: | Shakeel Modak, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Nai-Kong V. Cheung, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000534398, MSKCC-06072 |
Study First Received: | March 20, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00450827 |
Health Authority: | Unspecified |
recurrent neuroblastoma |
Neuroectodermal Tumors, Primitive Bevacizumab Neuroblastoma Recurrence Antibodies, Monoclonal Neuroectodermal Tumors Antibodies |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Iodine Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial Immunoglobulins |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Trace Elements Angiogenesis Inhibitors |
Pharmacologic Actions Anti-Infective Agents, Local Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Neoplasms, Neuroepithelial |