Expired Study
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Cleveland, Ohio 44195


Purpose:

RATIONALE: Interferon beta may interfere with the growth of tumor cells. PURPOSE: This phase II trial is studying how well interferon beta works in treating patients with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.


Study summary:

OBJECTIVES: - Determine the objective clinical response rate in patients with metastatic cutaneous or ocular melanoma treated with interferon beta. - Determine the frequency and degree of apoptosis induction in patients treated with this drug. - Determine the safety and tolerability of this drug in these patients. OUTLINE: This is an open-label study. Patients are stratified according to type of melanoma (ocular vs cutaneous). Patients receive interferon beta subcutaneously once daily in the absence of disease progression or unacceptable toxicity. Patients are followed within 3 days after completion of study treatment and then for survival. PROJECTED ACCRUAL: A total of 28-56 patients (14-28 per stratum) will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma - Cutaneous or ocular disease - Measurable disease - No active unstable CNS metastases by neurologic exam AND CT scan or MRI - Irradiated and/or resected CNS lesions allowed if there is no evidence of disease by head MRI or CT scan for > 6 months after surgery and/or radiotherapy - Patients with cutaneous metastases and previously irradiated and/or resected CNS metastases are eligible if the CNS metastases are controlled and do not require dexamethasone PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 (0-2 for patients with cutaneous metastases) Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count ≥ 1,200/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9.5 g/dL Hepatic - Bilirubin ≤ 1.5 mg/dL - AST ≤ 3.0 times normal - Alkaline phosphatase ≤ 2.5 times normal (10 times normal if due to bone metastases) - Hepatitis B surface antigen negative Renal - Creatinine ≤ 1.5 mg/dL Cardiovascular - No serious cardiac arrhythmia requiring treatment - No congestive heart failure - No angina pectoris - No New York Heart Association class II-IV heart disease - No other severe cardiovascular disease Other - HIV negative - No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the uterine cervix - No history of seizure disorder - No severe psychiatric disorder - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - More than 12 months since prior adjuvant interferon alfa-2 (IFNα-2) therapy - More than 30 days since prior IFNα-2 therapy for metastatic disease (6 months for patients with cutaneous metastases) - No more than 1 prior systemic regimen (chemotherapy or biologic) for metastatic disease (3 regimens for patients with cutaneous metastases) Chemotherapy - See Biologic therapy - No concurrent chemotherapy Endocrine therapy - See Disease Characteristics - Concurrent replacement therapy with physiologic doses of corticosteroids allowed - No concurrent dexamethasone or other steroidal antiemetics or anti-inflammatories - No other concurrent hormonal agents except steroids administered for preexisting adrenal failure or hormones administered for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy - See Disease Characteristics - More than 28 days since prior radiotherapy and recovered - No concurrent palliative radiotherapy Surgery - See Disease Characteristics - No prior organ allograft - More than 28 days since prior major surgery requiring general anesthesia Other - More than 28 days since prior antibiotics for local or systemic infection - No concurrent aspirin - No concurrent barbiturates - No other concurrent investigational agents


NCT ID:

NCT00085306


Primary Contact:

Study Chair
Ernest C. Borden, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44195
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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