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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.
ClinicalTrials.gov 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

June 28, 2005
June 29, 2005
April 1, 2008
March 2005
Not Provided
anti-tumor effects and systemic immune activation at 28 days
Same as current
Complete list of historical versions of study NCT00116363 on ClinicalTrials.gov Archive Site
  • tumor response
  • toxicity and safety
  • the induction of antigen-specific T-lymphocytes after multiple cycles of treatment
Same as current
Not Provided
Not Provided
Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma
Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma
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.
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Malignant Melanoma
  • Neoplasm Metastasis
Genetic: investigational drug INGN 241
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2006
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Central nervous system involvement by melanoma
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
INT 241-004
2003-0590, R43 CA 89778
Not Provided
Not Provided
Not Provided
Introgen Therapeutics
M.D. Anderson Cancer Center
Principal Investigator: Kevin B Kim, MD UT MD Anderson Cancer Center
Introgen Therapeutics
March 2008

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