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.
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
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.
- Conditions
- Stage IV Melanoma, Recurrent Melanoma
- 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 group | Role | What they receive |
|---|---|---|
| Recombinant interferon beta | Experimental | Not described Receives: Biological: recombinant interferon beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted11 Jun 2004 (estimated)
- Study startApr 2004
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV MelanomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ernest C. Borden, MD, Study chair, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma
- ClinicalTrials.gov ID
- NCT00085306
- Acronym / sponsor ID
- CASE1604
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant interferon beta | Experimental | Biological: recombinant interferon beta |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon betarecombinant interferon beta | Biological | Recombinant interferon beta |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest C. Borden, MD study chair
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
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.