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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Introgen Therapeutics.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by:
Introgen Therapeutics
ClinicalTrials.gov Identifier:
NCT00116363
First received: June 28, 2005
Last updated: March 28, 2008
Last verified: March 2008
  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 2

Introgen Therapeutics has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Introgen Therapeutics:
gene therapy
melanoma
adenovirus
in-transit melanoma
metastatic melanoma

Additional relevant MeSH terms:
Neoplasms
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014