Melanoma (Skin)
Conditions
Keywords
stage IV melanoma, recurrent melanoma
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.
Detailed description
OBJECTIVES: * Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa. * Determine the safety and tolerability of this regimen in this patient population. * Determine the changes in quality of life over time in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion. Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study. Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.
Interventions
BIOLOGICALaldesleukin
BIOLOGICALrecombinant interferon alfa
BIOLOGICALsargramostim
DRUGtemozolomide
Sponsors
Saint Francis Hospital
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable stage IV melanoma * Measurable metastatic disease * No uncontrolled brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * More than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 3 times ULN * Alkaline phosphatase no greater than 3 times ULN Renal: * BUN no greater than 1.5 times ULN * Creatinine no greater than 1.5 times ULN Cardiovascular: * No significant cardiovascular disease Other: * No non-malignant systemic disease * No acute infection requiring IV antibiotics * No alcohol or substance abuse * No other condition, disease, or history of other illness that would preclude study participation * No hypersensitivity, allergic reactions, or intolerance to study drugs * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No prior interleukin-2 * No other concurrent immunotherapy * No concurrent investigational vaccines or immunomodulatory agents * No other concurrent growth factors Chemotherapy: * At least 4 weeks since prior chemotherapy * No prior temozolomide * No other concurrent anticancer chemotherapy Endocrine therapy: * No concurrent steroids (including corticosteroids) Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 3 weeks since prior major surgery Other: * At least 30 days since prior immune-based therapy * No concurrent participation in other clinical trials with investigational drugs * No other concurrent anticancer drugs * No concurrent immunosuppressive therapy * No concurrent levamisole or cimetidine
Countries
United States
Outcome results
None listed