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

Primary Purpose

Stage IV Melanoma, Recurrent Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon beta
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Melanoma focused on measuring recurrent melanoma, stage IV melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recombinant interferon beta

Arm Description

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
October 1, 2015
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00085306
Brief Title
Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma
Official Title
Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Melanoma, Recurrent Melanoma
Keywords
recurrent melanoma, stage IV melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant interferon beta
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
recombinant interferon beta
Intervention Description
recombinant interferon beta
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest C. Borden, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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