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

Primary Purpose

Malignant Melanoma, Neoplasm Metastasis

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

investigational drug INGN 241

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring gene therapy, melanoma, adenovirus, in-transit melanoma, metastatic melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven melanoma, must have 3 regional metastatic lesions that are in transit Exclusion Criteria: Central nervous system involvement by melanoma

Sites / Locations

University of Texas MD Anderson Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

anti-tumor effects and systemic immune activation at 28 days

Secondary Outcome Measures

tumor response

toxicity and safety

the induction of antigen-specific T-lymphocytes after multiple cycles of treatment

Full Information

NCT ID

NCT00116363

First Posted

June 28, 2005

Last Updated

March 28, 2008

Sponsor

Introgen Therapeutics

Collaborators

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00116363

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Introgen Therapeutics

Collaborators

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma, Neoplasm Metastasis

Keywords

gene therapy, melanoma, adenovirus, in-transit melanoma, metastatic melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

investigational drug INGN 241

Primary Outcome Measure Information:

Title

anti-tumor effects and systemic immune activation at 28 days

Secondary Outcome Measure Information:

Title

tumor response

Title

toxicity and safety

Title

the induction of antigen-specific T-lymphocytes after multiple cycles of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically proven melanoma, must have 3 regional metastatic lesions that are in transit Exclusion Criteria: Central nervous system involvement by melanoma

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kevin B Kim, MD

Phone

800.392.1611

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin B Kim, MD

Organizational Affiliation

UT MD Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kevin Kim, MD

First Name & Middle Initial & Last Name & Degree

Julie Ellerhorst, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

35149587

Citation

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.

Results Reference

derived

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

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