Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

December 12, 2019 updated by: University of Wisconsin, Madison

Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial

RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous skin metastases.
  • Determine the antitumor immune response in patients treated with this regimen.
  • Compare the toxicity of this regimen administered for 1 week vs 2 weeks in these patients.
  • Compare the local and systemic antitumor response in patients treated with this regimen administered for 1 week vs 2 weeks.

OUTLINE: Patients are stratified according to number of tumor sites (1 vs 2 vs 3 or more). Patients are assigned to 1 of 2 treatment arms.

  • Group A: Patients receive interleukin-12 gene intratumorally over 5 minutes on days 1, 3, and 5.
  • Group B: Patients receive IL-12 gene intratumorally over 5 minutes on days 1, 3, 5, 8, 10, and 12.

Patients with stable or responding disease may receive 1 subsequent course beginning on day 29.

Patients are followed at 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 12 patients (6 per treatment group) will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid malignancy

    • Surgically or medically incurable disease
    • No standard chemotherapy or radiotherapy exists for this disease

  • Tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the skin

    • Cutaneous metastases, subcutaneous metastases, or tumor-involved lymph nodes that are easily palpable

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC greater than 3,000/mm^3
  • Platelet count greater than 80,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL

Renal:

  • Creatinine less than 2.0 mg/dL

Other:

  • HIV negative
  • No active infections requiring antibiotic, antiviral, or antifungal treatment
  • No other active malignancy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 1 month since prior immunotherapy
  • No concurrent colony-stimulating factors

Chemotherapy:

  • See Disease Characteristics
  • At least 1 month since prior chemotherapy

Endocrine therapy:

  • At least 1 month since prior steroids (other than intermittent use as an antiemetic or topical agent)
  • No concurrent steroids

Radiotherapy:

  • See Disease Characteristics
  • Prior radiotherapy to vaccine site allowed provided there is documentation of progressive disease

Surgery:

  • See Disease Characteristics
  • No prior organ allografts

Other:

  • No other concurrent antineoplastic therapy
  • No other concurrent investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David M. Mahvi, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Registration Dates

First Submitted

January 4, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069115
  • P30CA014520 (U.S. NIH Grant/Contract)
  • WCCC-CO-9771
  • WCCC-HSC-1998-257
  • NCI-T98-0025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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