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

Neoplasm Metastasis Clinical Trial

Official title:

Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00116363
• Other study ID #: INT 241-004
• Secondary ID: 2003-0590, R43 C
• Status: Recruiting
• Phase: Phase 2
• First received: June 28, 2005
• Last updated: March 28, 2008
• Start date: March 2005
• Est. completion date: December 2006

Study information

• Verified date: March 2008
• Source: Introgen Therapeutics
• Contact: Kevin B Kim, MD
• Phone: 800.392.1611
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Central nervous system involvement by melanoma

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma
• Neoplasm Metastasis

Intervention

Genetic:
• investigational drug INGN 241

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Introgen Therapeutics	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-tumor effects and systemic immune activation at 28 days
Secondary	tumor response
Secondary	toxicity and safety
Secondary	the induction of antigen-specific T-lymphocytes after multiple cycles of treatment