Completed

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

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What is being tested

recombinant interferon beta

Biological
Who is being recruted

Melanoma, Cutaneous Malignant
+9

+ Melanoma
+ Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorCase Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitlePhase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma 
NCT00085306
Principal SponsorCase Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
21 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Melanoma, Cutaneous Malignant
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Neuroectodermal Tumors
Nevi and Melanomas
Neuroendocrine Tumors
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

recombinant interferon beta
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, United StatesSee the location

CompletedOne Study Center
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