Title
Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
Phase
Phase 2Lead Sponsor
Saint Francis Memorial HospitalStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Melanoma (Skin)Intervention/Treatment
aldesleukin temozolomide sargramostim interferon alpha-2b ...Study Participants
NoneRATIONALE: 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.
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.
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
