Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Biological: interleukin-12 gene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: interleukin-12 gene|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin metastases