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

• Sponsor: Introgen Therapeutics (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00116363
• Collaborator: M.D. Anderson Cancer Center (Other)
• Enrollment: 25
• Location: 1
• Duration (Months): 21
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2005
• Anticipated Study Completion Date: Dec 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Introgen Therapeutics
• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Kevin B Kim, MD, UT MD Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00116363
• Other Study ID Numbers: INT 241-004; 2003-0590, R43 CA 89778
• First Posted: Jun 29, 2005
• Last Update Posted: Apr 1, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: gene therapy; melanoma; adenovirus; in-transit melanoma; metastatic melanoma
• Additional relevant MeSH terms: Melanoma; Neoplasm Metastasis

Study Results

No Results Posted as of Apr 1, 2008