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Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma

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. Identifier: NCT00116363
Recruitment Status : Unknown
Verified March 2008 by Introgen Therapeutics.
Recruitment status was:  Recruiting
First Posted : June 29, 2005
Last Update Posted : April 1, 2008
M.D. Anderson Cancer Center
Information provided by:
Introgen Therapeutics

Brief Summary:
This is a research study to look at the ways in which a treatment called INGN241 can kill melanoma cells or help the patient's immune system kill melanoma cells.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Neoplasm Metastasis Genetic: investigational drug INGN 241 Phase 2

Expanded Access : Introgen Therapeutics has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:
INGN 241 is an adenoviral vector carrying the MDA-7 cDNA. MDA-7 is a novel tumor suppressor molecule with cytokine properties, recently designated as IL-24. Over expression of MDA-7 in melanoma cells in vitro has been shown to inhibit cellular proliferation and induce apoptosis. Loss of MDA-7 expression in human melanomas has been shown to correlate with invasion and metastasis. The INGN 241 gene transfer construct has been previously used in human subjects in an ongoing open label Phase I study using intratumoral administration, and has been well tolerated to date. The primary objectives of the present study are to determine if INGN 241, injected into a melanoma in transit lesion, can induce apoptosis in regional uninjected lesions and initiate systemic immune activation. Secondary objectives include examination of specific immunity and of clinical response and toxicity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma
Study Start Date : March 2005
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. anti-tumor effects and systemic immune activation at 28 days

Secondary Outcome Measures :
  1. tumor response
  2. toxicity and safety
  3. the induction of antigen-specific T-lymphocytes after multiple cycles of treatment

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

Inclusion Criteria:

  • Histologically proven melanoma, must have 3 regional metastatic lesions that are in transit

Exclusion Criteria:

  • Central nervous system involvement by melanoma

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 identifier (NCT number): NCT00116363

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Contact: Kevin B Kim, MD 800.392.1611

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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Kevin Kim, MD         
Sub-Investigator: Julie Ellerhorst, MD         
Sponsors and Collaborators
Introgen Therapeutics
M.D. Anderson Cancer Center
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Principal Investigator: Kevin B Kim, MD UT MD Anderson Cancer Center
Layout table for additonal information Identifier: NCT00116363    
Other Study ID Numbers: INT 241-004
2003-0590, R43 CA 89778
First Posted: June 29, 2005    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008
Keywords provided by Introgen Therapeutics:
gene therapy
in-transit melanoma
metastatic melanoma
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes