Melanoma (Skin)Early Phase 1NCT00470379
Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery
A Early Phase 1 study testing resiquimod 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. Giving vaccine therapy together with resiquimod may make a stronger immune response and prevent or delay the recurrence of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- resiquimod
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Oct 2011
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Prior diagnosis of melanoma meeting the following criteria:
- Stage II-IV disease
- Complete resection of disease
- No current evidence of disease
- HLA-A2 positive
- No known standard therapy for disease that is potentially curative or proven capable of extending life expectancy exists
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 75,000/mm³
- AST ≤ 3 times upper limit of normal
- No uncontrolled or current infection
- No known allergy to vaccine or adjuvant components
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known immune deficiency
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy and recovered
- More than 4 weeks since prior biologic therapy
- No concurrent immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give vaccine therapy together with resiquimod in treating patients with stage II, stage III, or stage IV melanoma that has been completely removed by surgery.
Read the detailed description
OBJECTIVES:
- Determine the safety and immunization efficacy of the NY-ESO-1b peptide vaccine with resiquimod adjuvant in patients with completely resected stage II-IV melanoma.
- Collect, preliminarily, descriptive data on the impact of this regimen on time to melanoma relapse in these patients.
OUTLINE: This is a 3-step pilot, dose-escalation study of resiquimod.
- Step 1: Patients receive NY-ESO-1b peptide vaccine intradermally and topical resiquimod on day 1.
A cohort of 3-6 patients receives a maximal dose of resiquimod with NY-ESO-1b peptide vaccine.
- Step 2: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod on day 1.
Cohorts of 3-6 patients receive escalating doses of resiquimod until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
- Step 3: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod at the step 2 dose as in step 2.
Cohorts of 3-6 patients receive resiquimod to increasing amounts of surface area until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.
Blood is drawn at baseline and periodically during study treatment and observation. Samples are analyzed by flow cytometry, monoclonal antibody staining, ELISPOT, and ELISA.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- resiquimod
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resiquimodDrug
Escalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b.
| Study group | Role | What they receive |
|---|---|---|
| Immunization with NY-ESO-1b | Experimental | Efficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine. Receives: Drug: resiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of hematologic and non-hematologic toxicities
Measured: 4 weeks
Toxicity profile of each dose level
Measured: 4 weeks
Percent of patients who mount an immune response
Measured: 4 weeks
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 startApr 2006
- Primary completionOct 2011
- Study completionOct 2011
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT00470379
- Sponsor's protocol ID
- MC0578
- Other IDs
- P30CA015083, MC0578, 169-06
- Status last verified
- Jun 2012
- First submitted
- 3 May 2007
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
- ClinicalTrials.gov ID
- NCT00470379
- Acronym / sponsor ID
- MC0578
- Conditions
- Melanoma (Skin)
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (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. Giving vaccine therapy together with resiquimod may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give vaccine therapy together with resiquimod in treating patients with stage II, stage III, or stage IV melanoma that has been completely removed by surgery.
Detailed description
OBJECTIVES:
- Determine the safety and immunization efficacy of the NY-ESO-1b peptide vaccine with resiquimod adjuvant in patients with completely resected stage II-IV melanoma.
- Collect, preliminarily, descriptive data on the impact of this regimen on time to melanoma relapse in these patients.
OUTLINE: This is a 3-step pilot, dose-escalation study of resiquimod.
- Step 1: Patients receive NY-ESO-1b peptide vaccine intradermally and topical resiquimod on day 1.
A cohort of 3-6 patients receives a maximal dose of resiquimod with NY-ESO-1b peptide vaccine.
- Step 2: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod on day 1.
Cohorts of 3-6 patients receive escalating doses of resiquimod until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
- Step 3: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod at the step 2 dose as in step 2.
Cohorts of 3-6 patients receive resiquimod to increasing amounts of surface area until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.
Blood is drawn at baseline and periodically during study treatment and observation. Samples are analyzed by flow cytometry, monoclonal antibody staining, ELISPOT, and ELISA.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunization with NY-ESO-1b | Experimental | Drug: resiquimodEfficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine. |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| resiquimodEscalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b. | Drug | Immunization with NY-ESO-1b |
Primary outcome
Number and severity of hematologic and non-hematologic toxicities
Time frame: 4 weeks
Toxicity profile of each dose level
Time frame: 4 weeks
Percent of patients who mount an immune response
Time frame: 4 weeks
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 31 Oct 2014.
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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.
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 Early Phase 1 study testing resiquimod 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 31 Oct 2014. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number and severity of hematologic and non-hematologic toxicities (time frame: 4 weeks). The study lists 3 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 31 Oct 2014.