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| ID | Type | Description | Link |
|---|---|---|---|
| 2003-0590, R43 CA 89778 |
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| investigational drug INGN 241 | Genetic |
| Measure | Description | Time Frame |
|---|---|---|
| anti-tumor effects and systemic immune activation at 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| tumor response | ||
| toxicity and safety | ||
| the induction of antigen-specific T-lymphocytes after multiple cycles of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin B Kim, MD | Contact | 800.392.1611 |
| Name | Affiliation | Role |
|---|---|---|
| Kevin B Kim, MD | UT MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35149587 | Derived | Casciello F, Kelly GM, Ramarao-Milne P, Kamal N, Stewart TA, Mukhopadhyay P, Kazakoff SH, Miranda M, Kim D, Davis FM, Hayward NK, Vertino PM, Waddell N, Gannon F, Lee JS. Combined Inhibition of G9a and EZH2 Suppresses Tumor Growth via Synergistic Induction of IL24-Mediated Apoptosis. Cancer Res. 2022 Apr 1;82(7):1208-1221. doi: 10.1158/0008-5472.CAN-21-2218. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| D000257 | Adenoviridae Infections |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |