Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.

Detailed Description
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OBJECTIVES: Determine the response rate in patients with advanced melanoma treated with temozolomide and pegylated interferon alfa. Determine the toxicity profile of this regimen in these patients. Determine the duration of disease response and overall survival of patients treated with this regimen. OUTLINE: Patients are stratified according to CNS metastases (yes vs no). Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa subcutaneously once weekly on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 23-61 patients (12-35 without CNS metastases and 11-26 with CNS metastases) will be accrued for this study within 18 months.

Official Title
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A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma

Conditions
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Intraocular Melanoma, Melanoma (Skin)

Intervention / Treatment
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* Biological: pegylated interferon alfa
* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Unresectable stage III or stage IV disease Ocular, mucosal, or cutaneous melanoma Measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of severe cardiovascular disease No myocardial infarction within the past 6 months No unstable angina No New York Heart Association class III or IV heart disease (congestive heart failure) No ventricular tachyarrhythmias Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No AIDS-related illness No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) No serious infection requiring IV antibiotics No psychiatric disorder requiring ongoing therapy or medication No nonmalignant illness or other medical condition that would preclude study No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy and recovered No concurrent immunotherapy Chemotherapy: No prior dacarbazine No prior temozolomide No other concurrent chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery At least 3 weeks since prior radiotherapy to the brain for brain metastases Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At least 2 weeks since prior surgical procedure requiring general anesthesia and recovered

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pegylated interferon alfa|nan|
|Drug: temozolomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iris melanoma, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma