You are viewing an expired study

This study is not currently recruiting Study Participants on If you would like to find active studies please browse nearby listings below.

Click here to view additional nearby studies or search for clinical trials.

Madison, Wisconsin 53792

  • Metastatic Cancer


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 summary:

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.


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



Primary Contact:

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

Backup Contact:


Location Contact:

Madison, Wisconsin 53792
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source:

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on The form below is not enabled.