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

October 1, 2015 updated by: Case Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ernest C. Borden, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

June 10, 2004

First Submitted That Met QC Criteria

June 10, 2004

First Posted (Estimate)

June 11, 2004

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE1604 (Other Identifier: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH Grant/Contract)
  • CCF-4049 (Other Identifier: Cleveland Clinic IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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