Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2005 |
| End Date: | December 2006 |
| Contact: | Kevin B Kim, MD |
| Phone: | 800.392.1611 |
Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma
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.
melanoma cells or help the patient's immune system kill melanoma cells.
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.
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.
Inclusion Criteria:
- Histologically proven melanoma, must have 3 regional metastatic lesions that are in
transit
Exclusion Criteria:
- Central nervous system involvement by melanoma
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
Click here to add this to my saved trials
