Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma
Recruitment status was Recruiting
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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 |
- anti-tumor effects and systemic immune activation at 28 days
- 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 |
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 |
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| Contact: Kevin B Kim, MD | 800.392.1611 |
| 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 | |
| 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 May 22, 2013