Malignant MelanomaPhase 3NCT00052156
Vaccine Therapy for Patients With Stage IV Melanoma
A Phase 3 study testing CancerVax vaccine (CANVAXIN) in people with Malignant Melanoma, run by CancerVax Corporation at 77 sites in 13 countries.
Trial summary
This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- CancerVax vaccine (CANVAXIN)
- Type of treatment
- Vaccines
- How many people
- 670 participants
- Where
- 77 sitesin 13 countries
- Study dates
- Start not givento not given
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Must have Stage IV melanoma
- Must have had all clinically-detectable disease surgically removed
- Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy)
- Cannot have HIV or Hepatitis A, B, or C
Trial locations and contacts
77 sites in 13 countries.
77 sites in 13 countries
United States51 sites
Kaiser Permanente Medical Group
Anaheim, California
University of Colorado Cancer Center
Aurora, Colorado
St. Agnes Healthcare
Baltimore, Maryland, 21229
Franklin Square Hospital Center
Baltimore, Maryland, 21237
St. Lukes Hospital Cancer Center
Bethlehem, Pennsylvania, 18015
Boston Medical Center
Boston, Massachusetts, 02118-2393
Millard Fillmore Hospital
Buffalo, New York, 14209
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
UT Southwest Medical Center- Dallas
Dallas, Texas, 75235-9154
Dayton Clinical Oncology Group
Dayton, Ohio, 45409
Spectrum Health - Butterworth Campus
Grand Rapids, Michigan, 49546
The Cancer Cener at Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Wagner and Associates
Indianapolis, Indiana, 46256
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Cedars Sinai Comprehensive Cancer Center
Los Angeles, California
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland
Loyola University Medical Center
Maywood, Illinois
Mt. Sinai Comprehensive Cancer Center
Miami, Florida
University of Miami
Miami, Florida
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Columbia Presbyterian Medical Center
New York, New York, 10032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Intermountain Health Care- Mckay-Dee Hospital
Ogden, Utah, 84403
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Comprehensive Cancer Center at DRMC
Palm Springs, California, 92262
OSF Saint Francis Medica Center
Peoria, Illinois, 61637
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Medical Center of Princeton
Princeton, New Jersey, 08540
Kaiser Permanente Medical Group
Riverside, California
Intermountain Health Care-LDS Hospital
Salt Lake City, Utah, 84143
Kaiser Permanente Medical Group
San Diego, California, 92120
Sharp Hospital
San Diego, California, 92123
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
University of Washington
Seattle, Washington, 98109
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
Suny Health Science Center at Syracuse
Syracuse, New York, 13210
Northwest Medical Specialties
Tacoma, Washington, 98405
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Arizona Cancer Center
Tucson, Arizona, 85724
The Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
Wake Forest University
Winston-Salem, North Carolina
Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Germany7 sites
Klinikum Augsburg
Augsburg
Charite- University Medicine
Berlin
University of Jena
Jena, 07740
University Hospial of Mannheim
Mannheim
University of Tuebingen
Tübingen
University of Ulm
Ulm
University Hospital Wuerzburg
Würzburg
Australia6 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Peter MacCallum Cancer Center
Melbourne, Victoria, 3002
The Alfred Hospital
Melbourne, Victoria, 3181
Royal Prince Alfred Hospital, Sydney
Sydney, New South Wales, 2050
NSW Breast Cancer Institute
Westmead, New South Wales, 2145
Italy3 sites
Istituto Nazionale Tumori di Milano
Milan, Milan, 20133
Instituto Eurepeo di Oncologia
Milan, Milan, 20141
Istituto Nazionale dei Tumori
Naples, 80132
Brazil2 sites
INCA (National Cancer Institute)
Rio de Janeiro, 20230
Hospital Sirio Lebanes
São Paulo, 01308-050
About this study
Official title: A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma
This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.
- Conditions
- Malignant Melanoma
- Being tested
- CancerVax vaccine (CANVAXIN)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CancerVax vaccine (CANVAXIN)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 670 participants
Sponsor and investigators
- Lead sponsor
- CancerVax Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052156
- Sponsor's protocol ID
- CV-MMAIT-4-001
- Other IDs
- JWCI-MC-4-001
- Status last verified
- Apr 2005
- First submitted
- 23 Jan 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.
PubMed 29019177Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.
PubMed 22202581
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
- A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT00052156
- Acronym / sponsor ID
- CV-MMAIT-4-001
- Conditions
- Malignant Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 670 participants
- Lead sponsor
- CancerVax CorporationIndustry (pharma, biotech, devices)
- First posted
- 24 Jan 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.
This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- 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 |
|---|---|---|
| CancerVax vaccine (CANVAXIN) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 29019177Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.
- Derived from this study: PubMed 22202581Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.
- CancerVax Corporation WebsiteLink provided by the sponsor.
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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.
77 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CancerVax vaccine (CANVAXIN) in people with Malignant Melanoma, run by CancerVax Corporation at 77 sites in 13 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: status not confirmed, 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 77 sites in United States, Germany, Australia, Italy, Brazil and 8 more countries. 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 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT00052156, which also lists 2 linked publications.
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.