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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
Information provided by (Responsible Party):
Sheba Medical Center Identifier:
First received: February 2, 2006
Last updated: March 28, 2012
Last verified: March 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 Intervention Phase
Metastatic Melanoma
Procedure: Procedure - Adoptive cell transfer
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Response rate and toxicity [ Time Frame: 6 months ]

Estimated Enrollment: 70
Study Start Date: January 2006
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Procedure - Adoptive cell transfer
    Procedure - Adoptive cell transfer

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Brain mets
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00287131

Sheba Medical Center
Tel hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Jacob Schachter, MD Head, Ella Institute, Sheba Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sheba Medical Center Identifier: NCT00287131     History of Changes
Other Study ID Numbers: SHEBA-04-3518-JS-CTIL 
Study First Received: February 2, 2006
Last Updated: March 28, 2012

Keywords provided by Sheba Medical Center:
metastatic melanoma
adoptive immunotherapy

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas processed this record on February 20, 2017