Melanoma (Skin)Phase 1NCT00470015
Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma
A Phase 1 study testing MART-1 antigen, IL-2 and gp100 antigen in people with Melanoma (Skin), run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- MART-1 antigen, IL-2 and gp100 antigen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to 2 Jan 2013
- Phase
- Phase 1
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage II-IV disease
- Completely resected disease
- No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
- HLA-A2 positive
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm³
- Hemoglobin > 10 g/dL
- Platelet count ≥ 50,000/mm³
- AST ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled or current infection
- No known allergy to vaccine or immunoadjuvant components
- No known immune deficiency
PRIOR CONCURRENT THERAPY:
- No chemotherapy within the past 4 weeks and recovered
- No biologic therapy within the past 4 weeks
- No radiation therapy within the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.
Read the detailed description
OBJECTIVES:
- Determine the safety and toxicity profile of peptide vaccine comprising MART-1 antigen, gp100 antigen, and survivin antigen in combination with sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (IFA) with or without low-dose aldesleukin in patients with stage II-IV melanoma.
- Determine the immunologic effects of two different doses of GM-CSF coemulsified with melanoma peptides in IFA in these patients.
- Determine the immunological effects of low-dose aldesleukin therapy administered after peptide immunization in these patients.
- Collect preliminary data on the impact of the vaccine on clinical outcomes in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to disease stage (II vs III or IV). Patients are sequentially enrolled into 1 of 4 different dose schedules.
- Dose schedule 1: Patients receive gp100 antigen, MART-1 antigen, survivin antigen, and sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (peptide vaccine) subcutaneously (SC) on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Dose schedule 2: Patients receive peptide vaccine as in group 1. Patients also receive low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Dose schedule 3: Patients receive peptide vaccine as in group 1 except with a higher dose of GM-CSF. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Dose schedule 4: Patients receive peptide vaccine as in group 1 except with a higher dose of GM-CSF. Patients also receive low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 5 patients receive treatment at subsequent dose schedule until the maximum tolerated dose schedule (MTDS) is determined. The MTDS is defined as the dose schedule preceding that at which 2 of 5 patients experience dose-limiting toxicity within the first course.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- MART-1 antigen, IL-2, gp100 antigen, GM-CSF, MART-1a peptide
- Keywords
- stage II melanoma, stage III melanoma, 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.
MART-1 antigenBiological
1000 mcg; Day 1 of a 21 day cycle x 4
IL-2Biological
Also called Interleukin-2, Proleukin®, aldesleukin
0.5x10^6/m^2
gp100 antigenBiological
1000 mcg; Day 1 of a 21 day cycle x 4
GM-CSFBiological
Also called Leukine-Liquid, sargramostatin
300mcg
MART-1a peptideBiological
1000 mcg; Day 1 of a 21 day cycle x 4
| Study group | Role | What they receive |
|---|---|---|
| MART1 Analog, gp100 and Survivin | Experimental | Not described Receives: Biological: MART-1 antigen; Biological: IL-2; Biological: gp100 antigen; Biological: GM-CSF; Biological: MART-1a peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels
Measured: 12 weeks
Number and severity of hematologic and nonhematologic toxicities observed at each dose level
Measured: 12 weeks
Secondary outcomes (4)
Delayed-type hypersensitivity positivity
Measured: 12 weeks
Maximum percent change in CD4, CD8, CD14, CD19, and C20 levels from preimmunization levels
Measured: 12 weeks
Time to treatment failure
Measured: 12 weeks
Time to progression
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2009
- Study completion2 Jan 2013
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 Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Svetomir Markovic, MD, PhD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470015
- Sponsor's protocol ID
- CDR0000542631
- Other IDs
- P30CA015083, MC0575, 06-002650, NCI-2009-1306
- Status last verified
- Feb 2019
- First submitted
- 3 May 2007
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study
- ClinicalTrials.gov ID
- NCT00470015
- Acronym / sponsor ID
- CDR0000542631
- Conditions
- Melanoma (Skin)
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2007 (actual)
- Primary completion
- Apr 2009 (actual)
- Study completion
- 2 Jan 2013 (actual)
- First posted
- 7 May 2007 (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 peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.
Detailed description
OBJECTIVES:
- Determine the safety and toxicity profile of peptide vaccine comprising MART-1 antigen, gp100 antigen, and survivin antigen in combination with sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (IFA) with or without low-dose aldesleukin in patients with stage II-IV melanoma.
- Determine the immunologic effects of two different doses of GM-CSF coemulsified with melanoma peptides in IFA in these patients.
- Determine the immunological effects of low-dose aldesleukin therapy administered after peptide immunization in these patients.
- Collect preliminary data on the impact of the vaccine on clinical outcomes in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to disease stage (II vs III or IV). Patients are sequentially enrolled into 1 of 4 different dose schedules.
- Dose schedule 1: Patients receive gp100 antigen, MART-1 antigen, survivin antigen, and sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (peptide vaccine) subcutaneously (SC) on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Dose schedule 2: Patients receive peptide vaccine as in group 1. Patients also receive low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Dose schedule 3: Patients receive peptide vaccine as in group 1 except with a higher dose of GM-CSF. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Dose schedule 4: Patients receive peptide vaccine as in group 1 except with a higher dose of GM-CSF. Patients also receive low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 5 patients receive treatment at subsequent dose schedule until the maximum tolerated dose schedule (MTDS) is determined. The MTDS is defined as the dose schedule preceding that at which 2 of 5 patients experience dose-limiting toxicity within the first course.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MART1 Analog, gp100 and Survivin | Experimental | Biological: MART-1 antigen, Biological: IL-2, Biological: gp100 antigen, Biological: GM-CSF, Biological: MART-1a peptide |
Who may qualify
- Ages
- 18 to 120 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 |
|---|---|---|
| MART-1 antigen1000 mcg; Day 1 of a 21 day cycle x 4 | Biological | MART1 Analog, gp100 and Survivin |
| IL-2Also: Interleukin-2, Proleukin®, aldesleukin0.5x10^6/m^2 | Biological | MART1 Analog, gp100 and Survivin |
| gp100 antigen1000 mcg; Day 1 of a 21 day cycle x 4 | Biological | MART1 Analog, gp100 and Survivin |
| GM-CSFAlso: Leukine-Liquid, sargramostatin300mcg | Biological | MART1 Analog, gp100 and Survivin |
| MART-1a peptide1000 mcg; Day 1 of a 21 day cycle x 4 | Biological | MART1 Analog, gp100 and Survivin |
Primary outcome
Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels
Time frame: 12 weeks
Number and severity of hematologic and nonhematologic toxicities observed at each dose level
Time frame: 12 weeks
4 secondary outcomes
Delayed-type hypersensitivity positivity
Time frame: 12 weeks
Maximum percent change in CD4, CD8, CD14, CD19, and C20 levels from preimmunization levels
Time frame: 12 weeks
Time to treatment failure
Time frame: 12 weeks
Time to progression
Time frame: 24 months
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 19 Feb 2019.
Related trials for Melanoma (Skin)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Svetomir Markovic, MD, PhD study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MART-1 antigen, IL-2 and gp100 antigen in people with Melanoma (Skin), run by Mayo Clinic 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?
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 19 Feb 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels (time frame: 12 weeks). 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 19 Feb 2019.