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

This study is currently recruiting participants.
Verified March 2012 by Sheba Medical Center
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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Response rate and toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Brain mets
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287131

Contacts
Contact: Jacob Schachter, MD 972-3-5304907 Jacob.Schachter@sheba.health.gov.il
Contact: Aviad Yair 972-543355595 Aviad.Yair@sheba.health.gov.il

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

Publications:

Responsible Party: Sheba Medical Center
ClinicalTrials.gov 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
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
melanoma
metastatic melanoma
adoptive immunotherapy
IL-2

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 16, 2013