Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number and severity of hematologic and non-hematologic toxicities
Outcome Time Frame:
4 weeks
Safety Issue:
Yes
Principal Investigator
Svetomir Markovic, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
MC0578
NCT ID:
NCT00470379
Start Date:
April 2006
Completion Date:
October 2011
Related Keywords:
- Melanoma (Skin)
- stage II melanoma
- stage III melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
