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

NCT ID: NCT00116363

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Melanoma Neoplasm Metastasis

Keywords

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gene therapy melanoma adenovirus in-transit melanoma metastatic melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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investigational drug INGN 241

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Central nervous system involvement by melanoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Introgen Therapeutics

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kevin B Kim, MD

Role: PRINCIPAL_INVESTIGATOR

UT MD Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kevin B Kim, MD

Role: CONTACT

Phone: 800.392.1611

References

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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.

Reference Type DERIVED
PMID: 35149587 (View on PubMed)

Other Identifiers

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2003-0590, R43 CA 89778

Identifier Type: -

Identifier Source: secondary_id

INT 241-004

Identifier Type: -

Identifier Source: org_study_id