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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00698009 |
Primary Objective:
1. Evaluate safety, feasibility, persistence, and anti-tumor effect of infused haploidentical donor-derived natural killer (NK) cells and low-dose interleukin-2 (IL-2).
Secondary Objectives:
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: Fludarabine Drug: Cyclophosphamide Biological: Natural Killer Cell Infusion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study to Infuse Haploidentical Natural Killer Cells in Patients With Relapsed Neuroblastoma Post Autologous Stem Cell Transplant |
Estimated Enrollment: | 10 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Fludarabine + Cyclophosphamide + Natural Killer Cell Infusion
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Drug: Fludarabine
25 mg/m^2 IV Daily Over 30 minutes.
Drug: Cyclophosphamide
60 mg/kg IV Daily Over 2 Hours
Biological: Natural Killer Cell Infusion
Natural Killer Cell Infusion on Day 0.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Active infection.
Contact: Laurence Cooper, MD, PhD | 713-792-9860 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Laurence Cooper, MD, PhD |
Principal Investigator: | Laurence Cooper, MD, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Laurence Cooper, MD, PhD/Associate Professor ) |
Study ID Numbers: | 2006-0752 |
Study First Received: | June 12, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00698009 |
Health Authority: | United States: Food and Drug Administration |
Neuroblastoma Natural Killer Cell NK Cell Infusion Haploidentical Natural Killer (NK) Cells Fludarabine Fludarabine Phosphate Cyclophosphamide |
Cytoxan Neosar Infusion of NK cells Pediatric NK Cell Infusion Pediatric Neuroblastoma Pediatric NK Pediatric |
Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Neuroepithelioma Fludarabine |
Fludarabine monophosphate Cyclophosphamide Neuroectodermal Tumors, Primitive, Peripheral Neuroblastoma Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Alkylating Agents |