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
  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:


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
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 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 19, 2014