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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00287131
First received: February 2, 2006
Last updated: March 28, 2012
Last verified: March 2012

February 2, 2006
March 28, 2012
January 2006
December 2012   (final data collection date for primary outcome measure)
Response rate and toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Response rate and toxicity
Complete list of historical versions of study NCT00287131 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years and older
No
Contact: Jacob Schachter, MD 972-3-5304907 Jacob.Schachter@sheba.health.gov.il
Contact: Aviad Yair 972-543355595 Aviad.Yair@sheba.health.gov.il
Israel
 
NCT00287131
SHEBA-04-3518-JS-CTIL
No
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