Melanoma (Skin)Phase 2NCT00042783
Vaccine Therapy in Treating Patients With Stage IV Melanoma
A Phase 2 study testing D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant in people with Melanoma (Skin), run by SWOG Cancer Research Network at 7 sites in United States.
Trial summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant
- How many people
- Not given
- Where
- 7 sitesUnited States
- Study dates
- Sep 2002to Mar 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV melanoma that is considered incurable by surgery, radiotherapy, or limb perfusion
- M1a or M1b disease
- Measurable disease outside prior field of limb perfusion
- Metastatic mucosal melanoma allowed
- MAGE-3 positive by reverse transcription polymerase chain reaction
- No uveal or choroidal primary melanoma
- No prior or concurrent brain metastases by CT scan or MRI of the brain
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Hepatitis B surface antigen negative
- Hepatitis C negative
- No liver cirrhosis
- No unstable liver disease
- No coagulation disorders
Renal
- Not specified
Cardiovascular
- No major cardiovascular illness
- No myocardial infarction within the past 6 months
Pulmonary
- No major pulmonary illness
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No AIDS or HIV-1-associated complex
- No chronic alcohol abuse or drug addiction
- No systemic infections
- No prior active autoimmune disease
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently disease-free
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior adjuvant biologic therapy
- No prior biologic therapy for stage IV melanoma
- No prior MAGE-3 peptide or protein vaccine preparation
Chemotherapy
- At least 4 weeks since prior adjuvant chemotherapy
- No prior chemotherapy for stage IV melanoma
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior adjuvant radiotherapy
Surgery
- At least 4 weeks since prior surgery
Other
- See Disease Characteristics
- At least 3 weeks since prior limb perfusion and recovered
- At least 4 weeks since other prior adjuvant therapy
- No other prior therapy for stage IV melanoma
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
University of Washington School of Medicine
Seattle, Washington, 98195-6527
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant.
- Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen.
- Determine the 6-month progression-free survival rate of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine immune responses in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.
- Conditions
- Melanoma (Skin)
- Being tested
- D1/3-MAGE-3-His fusion protein, SB-AS02B adjuvant
- Keywords
- stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D1/3-MAGE-3-His fusion proteinBiological
SB-AS02B adjuvantBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Study completionMar 2006
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.
- More trials run by SWOG Cancer Research NetworkThe 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jeffrey S. Weber, MD, PhD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042783
- Sponsor's protocol ID
- CDR0000069468
- Other IDs
- SWOG-S0116
- Status last verified
- Apr 2004
- First submitted
- 5 Aug 2002
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00042783
- Acronym / sponsor ID
- CDR0000069468
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Study completion
- Mar 2006 (actual)
- First posted
- 27 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.
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
Detailed description
OBJECTIVES:
- Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant.
- Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen.
- Determine the 6-month progression-free survival rate of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine immune responses in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| D1/3-MAGE-3-His fusion protein | Biological | – |
| SB-AS02B adjuvant | Biological | – |
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 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.
Jeffrey S. Weber, MD, PhD study chair
University of Southern California
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant in people with Melanoma (Skin), run by SWOG Cancer Research Network at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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 2013.