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

Tracking Information
First Submitted Date ICMJE	February 2, 2006
First Posted Date ICMJE	February 6, 2006
Last Update Posted Date	March 29, 2012
Study Start Date ICMJE	January 2006
Estimated Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 18, 2008)	Response rate and toxicity [ Time Frame: 6 months ]
Original Primary Outcome Measures ICMJE; (submitted: February 2, 2006)	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 *	Besser MJ, Shapira-Frommer R, Treves AJ, Zippel D, Itzhaki O, Hershkovitz L, Levy D, Kubi A, Hovav E, Chermoshniuk N, Shalmon B, Hardan I, Catane R, Markel G, Apter S, Ben-Nun A, Kuchuk I, Shimoni A, Nagler A, Schachter J. Clinical responses in a phase II study using adoptive transfer of short-term cultured tumor infiltration lymphocytes in metastatic melanoma patients. Clin Cancer Res. 2010 May 1;16(9):2646-55. doi: 10.1158/1078-0432.CCR-10-0041. Epub 2010 Apr 20.; Nemlich Y, Greenberg E, Ortenberg R, Besser MJ, Barshack I, Jacob-Hirsch J, Jacoby E, Eyal E, Rivkin L, Prieto VG, Chakravarti N, Duncan LM, Kallenberg DM, Galun E, Bennett DC, Amariglio N, Bar-Eli M, Schachter J, Rechavi G, Markel G. MicroRNA-mediated loss of ADAR1 in metastatic melanoma promotes tumor growth. J Clin Invest. 2013 Jun;123(6):2703-18.
* 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; (submitted: March 28, 2012)	70
Original Enrollment ICMJE; (submitted: February 2, 2006)	20
Estimated Study 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	No
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	No
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