Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
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Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous skin metastases.
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Determine the antitumor immune response in patients treated with this regimen.
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Compare the toxicity of this regimen administered for 1 week vs 2 weeks in these patients.
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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.
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Group A: Patients receive interleukin-12 gene intratumorally over 5 minutes on days 1, 3, and 5.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed solid malignancy
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Surgically or medically incurable disease
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No standard chemotherapy or radiotherapy exists for this disease
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Tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the skin
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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:
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WBC greater than 3,000/mm^3
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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:
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HIV negative
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No active infections requiring antibiotic, antiviral, or antifungal treatment
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No other active malignancy
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
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At least 1 month since prior immunotherapy
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No concurrent colony-stimulating factors
Chemotherapy:
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See Disease Characteristics
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At least 1 month since prior chemotherapy
Endocrine therapy:
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At least 1 month since prior steroids (other than intermittent use as an antiemetic or topical agent)
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No concurrent steroids
Radiotherapy:
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See Disease Characteristics
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Prior radiotherapy to vaccine site allowed provided there is documentation of progressive disease
Surgery:
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See Disease Characteristics
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No prior organ allografts
Other:
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No other concurrent antineoplastic therapy
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No other concurrent investigational drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
Sponsors and Collaborators
- University of Wisconsin, Madison
- National Cancer Institute (NCI)
Investigators
- Study Chair: David M. Mahvi, MD, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000069115
- P30CA014520
- WCCC-CO-9771
- WCCC-HSC-1998-257
- NCI-T98-0025