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Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma, Neoplasm Metastasis

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Trial Information

Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma


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.


Inclusion Criteria:



- Histologically proven melanoma, must have 3 regional metastatic lesions that are in
transit

Exclusion Criteria:

- Central nervous system involvement by melanoma

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

anti-tumor effects and systemic immune activation at 28 days

Principal Investigator

Kevin B Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

INT 241-004

NCT ID:

NCT00116363

Start Date:

March 2005

Completion Date:

December 2006

Related Keywords:

  • Malignant Melanoma
  • Neoplasm Metastasis
  • gene therapy
  • melanoma
  • adenovirus
  • in-transit melanoma
  • metastatic melanoma
  • Neoplasms
  • Melanoma
  • Neoplasm Metastasis

Name

Location

University of Texas MD Anderson Cancer CenterHouston, Texas  77030