Metastatic Cancer
Conditions
Keywords
skin metastases
Brief 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.
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.
Interventions
BIOLOGICALinterleukin-12 gene
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed