MelanomaPhase 2/3NCT00055562
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma
A Phase 2/3 study testing CC 5013 in people with Melanoma and Neoplasm Metastasis, run by Celgene Corporation at 31 sites in 2 countries.
Trial summary
Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects will be treated in repeating 4 week cycles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Neoplasm Metastasis
- What is being tested?
- CC 5013
- How many people
- 274 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Jan 2003to Dec 2004
- Phase
- Phase 2/3
- 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
- Understand and voluntarily sign an informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug.
- Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States25 sites
University of Colorado
Aurora, Colorado, 80010
Massachusetts General Hospital
Boston, Massachusetts, 02214-2698
Beth Israel Deaconess Medical Ctr
Boston, Massachusetts, 02215-5400
The Linder Clinical Trial Center
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
Spectrum Health
Grand Rapids, Michigan, 49503
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Lakeland Regional Cancer Center
Lakeland, Florida, 33804-1057
University of Southern California Norris Cancer Center
Los Angeles, California, 90089
UCLA
Los Angeles, California, 90095-6956
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203-1632
Biomedical Research Alliance of New York
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Lutheran General
Park Ridge, Illinois, 60068-1270
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15232
St. Francis Memorial Hospital
San Francisco, California, 94109
Outpatient Clinic
Santa Monica, California, 90404
Washington University School of Medicine
St Louis, Missouri, 63110
Melanoma Center of St Louis
St Louis, Missouri, 63131
University of Arizona Cancer Center
Tucson, Arizona, 85724
Carle Clinic
Urbana, Illinois, 61801
The Harold Lever Regional Cancer Center
Waterbury, Connecticut, 06708
Canada6 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Qell Health Sciences Center
Halifax, Nova Scotia, B3H 2y9
L'Hotel Dieu de Quebec
Québec, Quebec, PQ G1R 2J6
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2 or IFN Based Therapy
Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects will be treated in repeating 4 week cycles.
- Conditions
- Melanoma, Neoplasm Metastasis
- Being tested
- CC 5013
- Keywords
- Metastatic Melanoma, Metastatic Malignant Melanoma, Revimid, CC5013
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC 5013Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2003 (estimated)
- Study startJan 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 274 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055562
- Sponsor's protocol ID
- CDC-5013-MEL-001
- Status last verified
- May 2004
- First submitted
- 5 Mar 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2 or IFN Based Therapy
- ClinicalTrials.gov ID
- NCT00055562
- Acronym / sponsor ID
- CDC-5013-MEL-001
- Conditions
- Melanoma, Neoplasm Metastasis
- Keywords
- Metastatic Melanoma, Metastatic Malignant Melanoma, Revimid, CC5013
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Dec 2004
- First posted
- 6 Mar 2003 (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.
Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects will be treated in repeating 4 week cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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 |
|---|---|---|
| CC 5013 | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CC 5013 in people with Melanoma and Neoplasm Metastasis, run by Celgene Corporation at 31 sites in 2 countries.
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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 24 Jun 2005.