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

NCT ID: NCT00085306

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2007-10-31

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.

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.

Conditions

Stage IV Melanoma; Recurrent Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Recombinant interferon beta

Group Type: EXPERIMENTAL

recombinant interferon beta

Intervention Type: BIOLOGICAL

recombinant interferon beta

Interventions

recombinant interferon beta

recombinant interferon beta

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ernest C. Borden, MD

Role: STUDY_CHAIR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCF-4049

Identifier Type: OTHER

Identifier Source: secondary_id

CASE1604

Identifier Type: OTHER

Identifier Source: secondary_id

CASE1604

Identifier Type: -

Identifier Source: org_study_id