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Home > "G" Clinical Trials Conditions > Gene Therapy in Treating Patients With Metastatic Melanoma  Gene Therapy in Treating Patients With Metastatic Melanoma
Gene Therapy in Treating Patients With Metastatic Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Colorado Cancer Center
Synopsis: RATIONALE: Inserting the gene for interleukin-2 into a person's melanoma cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have metastatic melanoma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of liposome complexed staphylococcal enterotoxin B and interleukin-2 plasmid DNA in patients with metastatic melanoma. II. Determine local gene expression in tumor tissues in this patient population treated with this regimen. III. Determine if plasmid DNA can be detected in circulation following intratumoral injection of this regimen in this patient population. IV. Evaluate the antitumor immune responses induced by this treatment regimen in these patients. V. Characterize the clinical response to this treatment regimen in terms of tumor size and histology in these patients. VI. Determine the clinical response to this treatment regimen in terms of complete remission, partial remission, stable disease, and disease progression in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive intratumoral liposome complexed staphylococcal enterotoxin B (SEB) and interleukin-2 (IL-2) plasmid DNA injections into 1-3 tumor nodules once every 2 weeks. Treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete regression during therapy may receive additional therapy to previously untreated tumor nodules. Patients with partial response at 4 weeks following the last injection may continue therapy once every 4 weeks until no residual tumor remains. Cohorts of 3 patients each receive escalating doses of SEB and IL-2 plasmid DNA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicities. Patients are followed until death. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic melanoma unresponsive to standard therapy or for which no curative therapy exists - No primary ocular melanoma - At least one cutaneous metastatic lesion measuring at least 1 cm in diameter - No untreated brain metastases by MRI or CT scan --Prior/Concurrent Therapy-- - See Disease Characteristics - At least 4 weeks since other prior anticancer therapy - No concurrent glucocorticosteroids --Patient Characteristics-- - Age: Over 18 - Performance status: SWOG 0-1 - Life expectancy: Greater than 2 months - Hematopoietic: WBC greater than 3,000/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 2.0 mg/dL; No active, acute, or chronic hepatitis - Renal: Creatinine less than 2.0 mg/dL - Cardiovascular: No unstable angina or complicated cardiovascular disease that would preclude catheterization - Immunologic: No active autoimmune disease or infection; Peripheral blood mononuclear cell proliferative response to 1 microgram/mL staphylococcal enterotoxin B in vitro, with a stimulation index of at least 5 - Other: HIV negative; No uncontrolled diabetes mellitus; No psychiatric illness that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy except nonmelanomatous skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickWalsh, Study Chair, University of Colorado Cancer Center
University of Colorado
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: CDR0000067832; UCHSC-GCRC-942,UCHSC-95-526
Study Start Date: February 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005943
Other Stage 4 Melanoma Studies:
1. Imatinib Mesylate in Treating Patients With Metastatic Melanoma
2. Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma
3. Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
4. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
5. Interferon alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Gene Therapy in Treating Patients With Metastatic Melanoma
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