Recruiting

Phase 2

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

Sponsor:

Introgen Therapeutics

Code:

NCT00116363

Conditions

Malignant Melanoma

Neoplasm Metastasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

investigational drug INGN 241

Study Details

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.

Conditions

Malignant Melanoma

Neoplasm Metastasis

Study ID

NCT00116363

Start date

Mar, 2005

Status verified date

Mar, 2008

Completion date

Dec, 2006

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

investigational drug INGN 241

Primary outcome measure

anti-tumor effects and systemic immune activation at 28 days [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Kevin B Kim, MD

800.392.1611

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Kevin Kim, MD

More Information

Sponsor

Introgen Therapeutics

Last update posted

Apr 1, 2008

Last verified

Mar, 2008

Keywords

gene therapy
melanoma
adenovirus
in-transit melanoma
metastatic melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Introgen Therapeutics on 2008-04-01.