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

Sponsor:

ClinicalTrials.gov Identifier:

NCT00287131

First Posted: February 6, 2006

Last Update Posted: March 29, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Sheba Medical Center

Tracking Information

First Submitted Date ^ICMJE

February 2, 2006

First Posted Date ^ICMJE

February 6, 2006

Last Update Posted Date

March 29, 2012

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response rate and toxicity [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Response rate and toxicity

Change History

Complete list of historical versions of study NCT00287131 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Melanoma

Intervention ^ICMJE

Procedure: Procedure - Adoptive cell transfer

Procedure - Adoptive cell transfer

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2013

Estimated Primary Completion Date

December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Brain mets

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Israel

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00287131

Other Study ID Numbers ^ICMJE

SHEBA-04-3518-JS-CTIL

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Sheba Medical Center

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jacob Schachter, MD

Head, Ella Institute, Sheba Medical Center

PRS Account

Sheba Medical Center

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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