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Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
This study has been completed.

First Received on January 4, 2002.   Last Updated on February 6, 2009   History of Changes
Sponsor: University of Wisconsin, Madison
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028652
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Biological: interleukin-12 gene
Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028652

Locations
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Study Chair: David M. Mahvi, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00028652     History of Changes
Other Study ID Numbers: CDR0000069115, WCCC-CO-9771, WCCC-HSC-1998-257, NCI-T98-0025
Study First Received: January 4, 2002
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
skin metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Interleukin-12
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012