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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
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by:
Introgen Therapeutics

Tracking Information
First Submitted Date  ICMJE June 28, 2005
First Posted Date  ICMJE June 29, 2005
Last Update Posted Date April 1, 2008
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2005)
anti-tumor effects and systemic immune activation at 28 days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2005)
  • tumor response
  • toxicity and safety
  • the induction of antigen-specific T-lymphocytes after multiple cycles of treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma
Official Title  ICMJE Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Melanoma
  • Neoplasm Metastasis
Intervention  ICMJE Genetic: investigational drug INGN 241
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: June 28, 2005)
25
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Central nervous system involvement by melanoma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00116363
Other Study ID Numbers  ICMJE INT 241-004
2003-0590, R43 CA 89778
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Introgen Therapeutics
Collaborators  ICMJE M.D. Anderson Cancer Center
Investigators  ICMJE
Principal Investigator: Kevin B Kim, MD UT MD Anderson Cancer Center
PRS Account Introgen Therapeutics
Verification Date March 2008

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