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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00085306
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : April 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Recombinant interferon beta Biological: recombinant interferon beta
recombinant interferon beta


Outcome Measures
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Primary Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085306


Locations
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United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Ernest C. Borden, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00085306    
Other Study ID Numbers: CASE1604
P30CA043703 ( U.S. NIH Grant/Contract )
CCF-4049 ( Other Identifier: Cleveland Clinic IRB )
CASE1604 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015
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:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Interferons
Interferon-beta
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs