Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma (NCT00085306) | Clinical Trial Compass
CompletedPhase 2
Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma
United States21 participantsStarted 2004-04
Plain-language 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) melanoma or ocular (eye) melanoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 nursi…
What they're measuring
1
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