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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00604136 |
Prior preclinical and clinical studies have shown that tumors from patients with advanced melanoma contain tumor-infiltrating lymphocytes (TIL) with anti-tumor reactivity. These TIL can be expanded in the laboratory to large numbers, and reinfused to the patient. Using a chemotherapy regimen that selectively kills lymphocytes, a single institution Phase II study of 35 patients showed a 51% objective response rate to TIL and interleukin-2 injection. In the present trial we would like to investigate whether we can achieve similar results in a Hadassah Phase II study, and to determine the feasibility of applying this approach to patients with advanced melanoma who currently have few treatment options.
Condition | Intervention | Phase |
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Metastatic Melanoma |
Biological: tumor infiltrating lymphocytes |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Treatment of Metastatic Melanoma Patients With Tumor Infiltrating Lymphocytes and IL-2 Following a Regimen of Non-Myeloablative Lymphocyte Depleting Chemotherapy |
Estimated Enrollment: | 20 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Tumor/TIL Harvest Exclusion Criteria:
Cell Infusion Exclusion Criteria:
The following patients will be excluded because of inability to receive high dose interleukin-2:
Responsible Party: | Hadassah Medical Organization ( Michal Lotem ) |
Study ID Numbers: | MS269- HMO-CTIL |
Study First Received: | January 17, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00604136 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
melanoma tumor infiltrating lymphocytes interleukin-2 |
Neuroectodermal Tumors Interleukin-2 Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Fludarabine |
Fludarabine monophosphate Cyclophosphamide Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |