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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287131
First Posted: February 6, 2006
Last Update Posted: March 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
February 2, 2006
February 6, 2006
March 29, 2012
January 2006
December 2012   (Final data collection date for primary outcome measure)
Response rate and toxicity [ Time Frame: 6 months ]
Response rate and toxicity
Complete list of historical versions of study NCT00287131 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients
Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Melanoma
Procedure: Procedure - Adoptive cell transfer
Procedure - Adoptive cell transfer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
70
November 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic Melanoma patients failing to prior chemo and immunotherapy with good performance status.

Exclusion Criteria:

  • Brain mets
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00287131
SHEBA-04-3518-JS-CTIL
No
Not Provided
Not Provided
Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Jacob Schachter, MD Head, Ella Institute, Sheba Medical Center
Sheba Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP