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Stage IV MelanomaPhase 2NCT00085306

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

A Phase 2 study testing recombinant interferon beta in people with Stage IV Melanoma and Recurrent Melanoma, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Melanoma, Recurrent Melanoma
What is being tested?
recombinant interferon beta
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Apr 2004to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
recombinant interferon beta
Keywords
recurrent melanoma, stage IV melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma
Medical subject headings
Melanoma, Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon betaBiological

    recombinant interferon beta

Study groups in NCT00085306
Study groupRoleWhat they receive
Recombinant interferon betaExperimentalNot described
Receives: Biological: recombinant interferon beta

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00085306
Sponsor's protocol ID
CASE1604
Other IDs
P30CA043703, CCF-4049, CASE1604
Status last verified
Oct 2015
First submitted
10 Jun 2004
Last updated
2 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant interferon beta in people with Stage IV Melanoma and Recurrent Melanoma, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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