Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma

Conditions
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Stage IV Melanoma, Recurrent Melanoma

Intervention / Treatment
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* Biological: recombinant interferon beta


Participation Criteria
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Eligibility Criteria
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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

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant interferon beta<br> | Biological: recombinant interferon beta<br>* recombinant interferon beta<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective clinical response rate to IFN-B the maximum tolerated dose as measured by a CTC Grade III hematologic or a Grade IV granulocyte toxicity which persists > 3 days at 1 week after each course |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent melanoma, stage IV melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma