Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Molgramostim; Sargramostim

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