Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

• Status: Completed
• Trial end date: 2003-12-01
• 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 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.

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

Details

• Lead Sponsor: Saint Francis Memorial Hospital
• Treatments: Aldesleukin; Interferon-alpha; Interferons; Sargramostim; Temozolomide

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