Melanoma Clinical Trial
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one drug with different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma.
Full Description
OBJECTIVES:
Determine the toxicity of cisplatin and dacarbazine followed by sargramostim (GM-CSF), interferon alfa, and interleukin-2 in patients with metastatic melanoma.
Determine the objective response rate, relapse free survival, and overall survival of these patients on this regimen.
OUTLINE: Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes sequentially on day 1, followed by sargramostim (GM-CSF) subcutaneously (SC) on days 2-7, interleukin-2 SC on days 8-14, and interferon alfa SC on days 8, 10, 12, and 14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression, and then every 8-12 weeks thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within 3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
Stage III with intransit metastases
Stage IV
No uncontrolled brain metastases by CT scan
No clinically significant ascites or pleural effusions
PATIENT CHARACTERISTICS:
Age:
Not specified
Performance status:
Karnofsky 70-100%
Life expectancy:
At least 10 weeks
Hematopoietic:
WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9.5 g/dL
Hepatic:
Bilirubin no greater than 2.0 mg/dL
SGOT no greater than 4 times upper limit of normal
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 70 mL/min
Cardiovascular:
No clinically significant cardiac disease on EKG, echocardiogram, or MUGA scan
Pulmonary:
No clinically significant pulmonary disease on chest x-ray
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No significant thyroid dysfunction
No concurrent severe infection
No other medical or psychiatric condition that would interfere with compliance
No second malignancy within the past 5 years, except:
Localized nonmelanomatous skin cancer
Carcinoma in situ of the cervix
Grade 1 Ta bladder cancer
Suspected hearing deficits must undergo audiologic testing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No more than one prior immunotherapy regimen
At least 4 weeks since prior immunotherapy
Adjuvant interferon alfa before relapse allowed
Chemotherapy:
No more than one prior chemotherapy regimen
At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
No concurrent cyclophosphamide
No other concurrent chemotherapy
Endocrine therapy:
No concurrent corticosteroids or cyclosporine A
Radiotherapy:
At least 2 weeks since prior radiotherapy
Surgery:
At least 3 weeks since major surgery
Other:
No concurrent immunosuppressive drugs
No other concurrent investigational antineoplastic drugs
Concurrent thyroid replacement therapy allowed
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There is 1 Location for this study
Chicago Illinois, 60637, United States
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