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

Saint Francis Hospital

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Biological: sargramostim; Drug: temozolomide; Biological: recombinant interferon alfa; Biological: aldesleukin

Study type: Interventional

Funder types: Other

Identifiers

NCT00014092

SFMH-BB-IND-5301

NCI-V00-1591

CDR0000067958

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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