Ciliary Body and Choroid Melanoma, Medium/Large SizePhase 2NCT00089063
Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma
A Phase 2 study testing tyrosinase peptide, gp100 antigen and MART-1 antigen in people with Ciliary Body and Choroid Melanoma, Medium/Large Size and Extraocular Extension Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma
- What is being tested?
- tyrosinase peptide, gp100 antigen and MART-1 antigen
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033-0804
About this study
Official title: 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
This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make a stronger immune response.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IIIA Melanoma
- Being tested
- tyrosinase peptide, gp100 antigen, MART-1 antigen, incomplete Freund's adjuvant, Montanide ISA 51 VG
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tyrosinase peptideBiological
Given SC
gp100 antigenBiological
Given SC
MART-1 antigenBiological
Given SC
incomplete Freund's adjuvantBiological
Given SC
Montanide ISA 51 VGDrug
Given SC
sargramostimBiological
Given SC
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (vaccine therapy) | Experimental | 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). Receives: Biological: tyrosinase peptide; Biological: gp100 antigen; Biological: MART-1 antigen; Biological: incomplete Freund's adjuvant; Drug: Montanide ISA 51 VG; Other: laboratory biomarker analysis |
| Arm II (vaccine therapy, sargramostim) | Experimental | 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. Receives: Biological: tyrosinase peptide; Biological: gp100 antigen; Biological: MART-1 antigen; Biological: incomplete Freund's adjuvant; Drug: Montanide ISA 51 VG; Biological: sargramostim; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response
Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
Measured: Baseline
Immune response
Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
Measured: Week 106
Secondary outcomes (2)
Disease-free survival
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.
Measured: Up to 2 years
Overall survival
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startJun 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ciliary Body and Choroid Melanoma, Medium/Large SizeStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey Weber, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089063
- Sponsor's protocol ID
- NCI-2012-02618
- Other IDs
- NCI-2012-02618, LAC-USC-042011, NCI-6618, LAC-USC-0A1033, CDR0000378033, 10M-03-8, 6618
- Status last verified
- Oct 2013
- First submitted
- 4 Aug 2004
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00089063
- Acronym / sponsor ID
- NCI-2012-02618
- Conditions
- Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IIIA Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 5 Aug 2004 (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 randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make a stronger immune response.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (vaccine therapy) | Experimental | Biological: tyrosinase peptide, Biological: gp100 antigen, Biological: MART-1 antigen, Biological: incomplete Freund's adjuvant, Drug: Montanide ISA 51 VG, Other: laboratory biomarker analysisPatients 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). |
| Arm II (vaccine therapy, sargramostim) | Experimental | Biological: tyrosinase peptide, Biological: gp100 antigen, Biological: MART-1 antigen, Biological: incomplete Freund's adjuvant, Drug: Montanide ISA 51 VG, Biological: sargramostim, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study provided that
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| tyrosinase peptideGiven SC | Biological | Arm I (vaccine therapy), Arm II (vaccine therapy, sargramostim) |
| gp100 antigenGiven SC | Biological | Arm I (vaccine therapy), Arm II (vaccine therapy, sargramostim) |
| MART-1 antigenGiven SC | Biological | Arm I (vaccine therapy), Arm II (vaccine therapy, sargramostim) |
| incomplete Freund's adjuvantGiven SC | Biological | Arm I (vaccine therapy), Arm II (vaccine therapy, sargramostim) |
| Montanide ISA 51 VGGiven SC | Drug | Arm I (vaccine therapy), Arm II (vaccine therapy, sargramostim) |
| sargramostimGiven SC | Biological | Arm II (vaccine therapy, sargramostim) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (vaccine therapy), Arm II (vaccine therapy, sargramostim) |
Primary outcome
Immune response
Time frame: Baseline
Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
Immune response
Time frame: Week 106
Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
2 secondary outcomes
Disease-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
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 15 Apr 2015.
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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 Weber principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tyrosinase peptide, gp100 antigen and MART-1 antigen in people with Ciliary Body and Choroid Melanoma, Medium/Large Size and Extraocular Extension Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Immune response (time frame: Baseline). The study lists 2 primary outcomes in all. 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 15 Apr 2015.