Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients
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|ClinicalTrials.gov Identifier: NCT00287131|
Recruitment Status : Unknown
Verified March 2012 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : February 6, 2006
Last Update Posted : March 29, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Procedure: Procedure - Adoptive cell transfer||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||November 2013|
- Procedure: Procedure - Adoptive cell transfer
Procedure - Adoptive cell transfer
- Response rate and toxicity [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287131
|Contact: Jacob Schachter, MD||972-3-5304907||Jacob.Schachter@sheba.health.gov.il|
|Contact: Aviad Yair||972-543355595||Aviad.Yair@sheba.health.gov.il|
|Principal Investigator:||Jacob Schachter, MD||Head, Ella Institute, Sheba Medical Center|