- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00089063
Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma
A Randomized Phase II Continuation Booster Trial After A Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 and ISA 51 VG With Or Without GM-CSF For Patients With Resected Stages IIB/C, III And IV Melanoma
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate immune reactivity to a tyrosinase:368-376 (370D) /gp100: 209-217 (210M)/MART-1 26-35 (27L) peptide vaccine with Montanide ISA 51 with or without GM-CSF administered as a booster for five vaccinations over two years.
OUTLINE: This is a randomized, parallel, continuation study. Patients are stratified according to response to prior vaccination (response to 1 peptide vs response to 2 or more peptides). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG subcutaneously (SC) on day 1 of weeks 0, 26, 52, 78, and 104 (total of 5 vaccinations).
Arm II: Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG as in arm I. Patients also receive sargramostim (GM-CSF) SC on days 1-5 of weeks 0, 26, 52, 78, and 104.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2-4 weeks, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study within 1 year.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033-0804
- University of Southern California
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study provided that
- They have received all injections with evidence of an immune response
- They have not experienced recurrence of the melanoma
- Not more than twelve months have elapsed since the final injection on either protocol
- They experienced no grade 3 or 4 toxicity attributed to the prior vaccine regimen
- Serum creatinine of 2.0 mg/dl or less
- Total bilirubin of 2.0 mg/dl or less
- SGOT/SGPT of 2.5 X institutional norm or less
- Total WBC of 3,000 or more
- At least 1500 granulocytes
- Hemoglobin of 9.0 gm/dl or more
- Platelet count of 100,000 per cu mm. or more
- ECOG performance status of 0 or 1
- Patients will be eligible for this trial if they have failed alpha-interferon, if it is felt to be contraindicated due to a pre-existing medical or psychiatric condition or if they have refused treatment with it
- Ability to read, understand and willingness to sign an IRB-approved informed consent
- Patients who have had another malignancy but with no evidence of disease for greater than 5 years from accrual to the current trial will be eligible if it is felt they are likely to be cured; patients with squamous or basal carcinoma of the skin or carcinoma in situ of the cervix that have been treated with curative intent can be accrued to this trial 30 days after treatment
Exclusion Criteria:
- Who have undergone any other systemic therapy for their melanoma, including radiation therapy since completion of 10M-01-1 or 10M-00-4
- Have major systemic infections like pneumonia or sepsis, coagulation or bleeding disorders, or other major medical illnesses of the gastrointestinal, cardiovascular or respiratory systems
- Who require systemic, ocular or inhaled corticosteroids
- Who are pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase, MART-1 or gp100 is felt to present a risk to the fetus or a breast feeding infant; effective birth control for men and women is required during and for four months after the study is finished
- Who are known to be positive for hepatitis BsAg, hepatitis C antibody or HIV antibody; since cells removed for ex vivo handling and tissue culture cannot be virus positive, and the effects of melanoma peptides might be detrimental to HIV positive patients, patients positive for the above viruses will not be treated on this trial
- Who have had a known allergic reaction to GM-CSF, Montanide ISA 51 (IFA) or any of the peptides included in this protocol
- Who have a prior history of uveitis or autoimmune inflammatory eye disease, immune hemolytic anemia or other active autoimmune disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (vaccine therapy)
Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG SC on day 1 of weeks 0, 26, 52, 78, and 104 (total of 5 vaccinations).
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Correlative studies
Given SC
Given SC
Given SC
Given SC
Given SC
|
Experimental: Arm II (vaccine therapy, sargramostim)
Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG as in arm I. Patients also receive sargramostim (GM-CSF) SC on days 1-5 of weeks 0, 26, 52, 78, and 104.
|
Correlative studies
Given SC
Given SC
Given SC
Given SC
Given SC
Given SC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune response
Time Frame: Baseline
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Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
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Baseline
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Immune response
Time Frame: Week 106
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Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
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Week 106
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival
Time Frame: Up to 2 years
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Kaplan-Meier curves will be drawn to display the survival and time to recurrence.
The log-rank test and estimates of relative risk based on the log-rank statistics will be performed.
95% confidence intervals will be constructed for the median DFS and OS.
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Up to 2 years
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Overall survival
Time Frame: Up to 2 years
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Kaplan-Meier curves will be drawn to display the survival and time to recurrence.
The log-rank test and estimates of relative risk based on the log-rank statistics will be performed.
95% confidence intervals will be constructed for the median DFS and OS.
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Up to 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey Weber, University of Southern California
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02618 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- LAC-USC-042011
- NCI-6618
- LAC-USC-0A1033
- CDR0000378033
- 10M-03-8 (University of Southern California)
- 6618 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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