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

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.
 
ClinicalTrials.gov Identifier: NCT00287131
Recruitment Status : Unknown
Verified March 2012 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : February 6, 2006
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metastatic Melanoma Procedure: Procedure - Adoptive cell transfer Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients
Study Start Date : January 2006
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Intervention Details:
  • Procedure: Procedure - Adoptive cell transfer
    Procedure - Adoptive cell transfer

Outcome Measures
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Primary Outcome Measures :
  1. Response rate and toxicity [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287131


Contacts
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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
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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
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Principal Investigator: Jacob Schachter, MD Head, Ella Institute, Sheba Medical Center
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00287131    
Other Study ID Numbers: SHEBA-04-3518-JS-CTIL
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Keywords provided by Sheba Medical Center:
melanoma
metastatic melanoma
adoptive immunotherapy
IL-2
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas