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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00085306

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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) melanoma or ocular (eye) melanoma.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Melanoma Recurrent Melanoma	Biological: recombinant interferon beta	Phase 2

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Recombinant interferon beta	Biological: recombinant interferon beta recombinant interferon beta

Arm

Intervention/Treatment

Experimental: Recombinant interferon beta

Biological: recombinant interferon beta

recombinant interferon beta

Outcome Measures

Primary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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