Status:
COMPLETED
Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage IV Melanoma
Recurrent Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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) ...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00085306
Start Date
April 1 2004
End Date
October 1 2007
Last Update
October 2 2015
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195