Expired Study
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Madison, Wisconsin 53792


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.


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.


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


NCT ID:

NCT00028652


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53792
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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