Melanoma (Skin)Phase 2NCT00128583
Vaccine Therapy in Treating Patients With Malignant Melanoma
A Phase 2 study testing polyvalent melanoma vaccine in people with Melanoma (Skin), run by CancerVax Corporation at 11 sites in 2 countries.
Trial summary
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- polyvalent melanoma vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 11 sitesin 2 countries
- Study dates
- Jul 2005to not given
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant melanoma
- At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter
PATIENT CHARACTERISTICS:
Age
- 18 to 80
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
CCOP - Dayton
Dayton, Ohio, 45429
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, 33804-1057
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
LDS Hospital
Salt Lake City, Utah, 84143
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, 90404
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
Australia2 sites
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
About this study
Official title: Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.
Read the detailed description
OBJECTIVES:
- Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).
OUTLINE: This is an open-label, multicenter study.
Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™).
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- polyvalent melanoma vaccine
- Keywords
- stage III melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyvalent melanoma vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies 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
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- CancerVax Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Linda Strause, Study chair, CancerVax Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128583
- Sponsor's protocol ID
- CDR0000439529
- Other IDs
- CV-MMAIT-5-001
- Status last verified
- Sep 2005
- First submitted
- 8 Aug 2005
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
- ClinicalTrials.gov ID
- NCT00128583
- Acronym / sponsor ID
- CDR0000439529
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- CancerVax CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- First posted
- 10 Aug 2005 (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: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.
Detailed description
OBJECTIVES:
- Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).
OUTLINE: This is an open-label, multicenter study.
Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™).
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| polyvalent melanoma vaccine | Biological | – |
Primary outcome
Response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Linda Strause study chair
CancerVax Corporation
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing polyvalent melanoma vaccine in people with Melanoma (Skin), run by CancerVax Corporation at 11 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: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. 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?
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.
What does the primary outcome measure?
Response. 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 19 Dec 2013.