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Home > "I" Clinical Trials Conditions > Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases  Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
For Condition: skin metastases
Status: No longer recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidMahvi, Study Chair, University of Wisconsin Comprehensive Cancer Center
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Additional Information:
Study ID Numbers: CDR0000069115; WCCC-HSC-1998-257,NCI-T98-0025,WCCC-CO-9771
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028652
Other Skin Metastases Studies:
1. Acitretin in Treating Patients With Skin Disease or Skin Cancer
2. Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
Related Studies:
Other skin metastases Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
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