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Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

Metastatic Melanoma Clinical Trial

Official title:
Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

Clinical Trial Summary

Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma.

Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in Israel.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00287131
Study type Interventional
Source Sheba Medical Center
Contact Jacob Schachter, MD
Phone 972-3-5304907
Email Jacob.Schachter@sheba.health.gov.il
Status Recruiting
Phase Phase 2
Start date January 2006
Completion date November 2013
View Details
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