Stage IV Melanoma Clinical Trial
Official title:
Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma
Verified date | February 2024 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy and interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma that has not responded to previous treatment.
Status | Completed |
Enrollment | 0 |
Est. completion date | March 2007 |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | All |
Age group | 16 Years and older |
Eligibility | PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of metastatic melanoma that has failed standard therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Prior surgery allowed --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0 or 1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL ALT/AST less than 2 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major respiratory disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No autoimmune disease No primary or secondary immunodeficiency HIV negative |
Country | Name | City | State |
---|---|---|---|
United States | Surgery Branch | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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