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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00085306
First received: June 10, 2004
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Stage IV Melanoma
Recurrent Melanoma
Biological: recombinant interferon beta
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

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 [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: April 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recombinant interferon beta Biological: recombinant interferon beta
recombinant interferon beta

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085306

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Ernest C. Borden, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ernest C.Borden, M.D., Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00085306     History of Changes
Other Study ID Numbers: CASE1604, P30CA043703, CCF-4049, CASE1604
Study First Received: June 10, 2004
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
recurrent melanoma
stage IV melanoma
iris melanoma
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
recurrent intraocular melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Interferon-beta
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014