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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00877110 |
The goal of this study is to see if it is safe and feasible to give chemotherapy, natural killer (NK) cells, and an antibody called 3F8. The NK cells must come from a family member who shares half of the HLA proteins which are immune proteins important in transplant. NK cells are a type of white blood cell. They can recognize and kill abnormal cells in the body and can work together with antibodies to kill target cells. The antibody 3F8 specifically recognizes a protein present on the target cancer cell.
Condition | Intervention | Phase |
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Neuroblastoma Bone Marrow, Sympathetic Nervous System |
Other: cyclophosphamide, vincristine, topotecan ,allogeneic NK cells & 3F8 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma |
Estimated Enrollment: | 36 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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chemotherapy, allogeneic NK cells, 3F8: Experimental
This is a phase I study to assess the safety and feasibility of combining HLA-mismatched (KIR ligand incompatible) NK cells with 3F8 in high-risk NB patients. Following chemotherapy with CTV, patients will be treated in sequential groups of 3-10 patients/dose of NK cells. Three dose levels of NK cells, starting at dose level I, will be evaluated in this treatment protocol. In the unlikely case toxicity is encountered at dose level I, patients will then be treated at the lower dose level 0.
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Other: cyclophosphamide, vincristine, topotecan ,allogeneic NK cells & 3F8
Patients will receive combination chemotherapy with intravenous (IV) cyclophosphamide 70mg/kg/day (for patients with body weight<70kg) or 2100mg/m2/day (for patients with body weight ≥70kg) for two days, IV vincristine 0.067mg/kg or 2mg/m2/day (lower of the two doses to be chosen; maximum 2mg) for one day, and IV topotecan 2.4 mg/m2/day for 3 days. On Day 0, patients will receive a single dose of allogeneic NK cells isolated from a HLA-haploidentical related donor. On day +3, the patient will start daily infusion of 3F8 for 5 days.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Donor Eligibility
Exclusion Criteria:
Contact: Shakeel Modak, MD | 212-639-7623 | |
Contact: Katharine Hsu, M.D., Ph.D. | 646-888-2667 |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Shakeel Modak, MD 212-639-7623 | |
Contact: Katharine Hsu, M.D., Ph.D. 646-888-2667 | |
Principal Investigator: Shakeel Modak, MD |
Principal Investigator: | Shakeel Modak, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Shakeel Modak, M.D. ) |
Study ID Numbers: | 09-011 |
Study First Received: | April 6, 2009 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00877110 History of Changes |
Health Authority: | United States: Food and Drug Administration |
BETA-D-GLUCAN CYCLOPHOSPHAMIDE (CYTOXAN) MAB 131 I - 3F8 TOPOTECAN |
VINCRISTINE Neuroblastoma 09-011 |
Neuroectodermal Tumors, Primitive Immunologic Factors Vincristine Antimitotic Agents Cyclophosphamide Immunosuppressive Agents Neuroblastoma Neuroectodermal Tumors Antibodies Neoplasms, Germ Cell and Embryonal |
Tubulin Modulators Neuroepithelioma Antineoplastic Agents, Alkylating Antirheumatic Agents Topotecan Antineoplastic Agents, Phytogenic Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial Immunoglobulins |
Neuroectodermal Tumors, Primitive Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Neuroblastoma Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Mitosis Modulators Vincristine Enzyme Inhibitors |
Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Topotecan Neoplasms, Neuroepithelial Antirheumatic Agents Antineoplastic Agents, Phytogenic Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |