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

This study is currently recruiting participants.

Verified by Introgen Therapeutics, March 2008

First Received: June 28, 2005 Last Updated: March 28, 2008 History of Changes

Sponsors and Collaborators:	Introgen Therapeutics M.D. Anderson Cancer Center
Information provided by:	Introgen Therapeutics
ClinicalTrials.gov Identifier:	NCT00116363

Purpose

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	Intervention	Phase
Malignant Melanoma Neoplasm Metastasis	Genetic: investigational drug INGN 241	Phase II

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma

Further study details as provided by Introgen Therapeutics:

Primary Outcome Measures:

anti-tumor effects and systemic immune activation at 28 days

Secondary Outcome Measures:

tumor response
toxicity and safety
the induction of antigen-specific T-lymphocytes after multiple cycles of treatment

Estimated Enrollment:	25
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116363

Contacts

Contact: Kevin B Kim, MD

800.392.1611

Locations

United States, Texas
University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Kevin Kim, MD
Sub-Investigator: Julie Ellerhorst, MD

Sponsors and Collaborators

Introgen Therapeutics

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Kevin B Kim, MD

UT MD Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	INT 241-004, 2003-0590, R43 CA 89778
Study First Received:	June 28, 2005
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00116363 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Introgen Therapeutics:

gene therapy
melanoma
adenovirus
in-transit melanoma
metastatic melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Adenoviridae Infections
Neoplasm Metastasis

Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Neoplasm Metastasis
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009