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TerminatedNCT00028652Updated Dec 13, 2019

Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

A Phase 1 interventional study of interleukin-12 gene in Metastatic Cancer, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-12-13.

Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years to 120 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Metastatic Cancer

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Keywords

  • skin metastases
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

Browse Neoplasm Metastasis studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • Biologicalinterleukin-12 gene
06

Study locations

1 site
  • University of Wisconsin Comprehensive Cancer Center
    Madison, Wisconsin 53792-6164, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00028652
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Jan 2002
Last update
Dec 13, 2019

Study contacts

David M. Mahvi, MD
study chair · University of Wisconsin, Madison
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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