Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma

University of Chicago46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma (Skin)

Interventions

CisplatinDRUG

dacarbazineDRUG

Granulocyte-macrophage colony-stimulating factorDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Objective response rate

Time frame: 2 years

Data from ClinicalTrials.gov

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