Adoptive Cell Therapy Following Non-Myeloablate Chemotherapy in Metastatic Melanoma Patients - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00287131

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 II

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Adoptive Cell Therapy Following Non-Myeloablate Chemotherapy in Metastatic Melanoma Patients

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:	20
Study Start Date:	January 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Responsible Party:	Sheba Medical Center ( Ella Institute for treatment and research of melanoma and skin cancer )
Study ID Numbers:	SHEBA-04-3518-JS-CTIL
Study First Received:	February 2, 2006
Last Updated:	May 18, 2008
ClinicalTrials.gov Identifier:	NCT00287131
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

melanoma
metastatic melanoma
adoptive immunotherapy
IL-2

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009