Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
|Melanoma (Skin)||Biological: incomplete Freund's adjuvant Biological: multi-epitope melanoma peptide vaccine Biological: sargramostim Biological: tetanus toxoid helper peptide Drug: dimethyl sulfoxide Drug: imiquimod Procedure: adjuvant therapy||Phase 1|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma|
- Safety if less than 33% of patients experience a dose-limiting at day 22
- Immune response by Elispot assay at day 22
|Study Start Date:||November 2004|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
- Determine the safety of adjuvant transdermal vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) in combination with Montanide ISA-51 or dimethyl sulfoxide with or without imiquimod in patients who have undergone surgical resection for stage II-IV melanoma.
- Determine, preliminarily, the immunogenicity of these regimens in these patients.
- Correlate, preliminarily, transdermal administration of these vaccines with the recruitment and maturation of epidermal Langerhans cells in these patients.
- Determine, preliminarily, the effects of timing of subsequent vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51, administered intradermally and subcutaneously, on the persistence of immune response in these patients.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) emulsified in Montanide ISA-51 transdermally (TD) on days 1, 8, and 15. Patients then receive the vaccine intradermally (ID) and subcutaneously (SC) on days 29, 50, 71, 92, 113, and 134.
- Arm II: Patients receive vaccine therapy as in arm I. Patients also receive imiquimod topically on days 0, 7, and 14.
- Arm III: Patients receive vaccine therapy comprising MP, TET, GM-CSF, and dimethyl sulfoxide TD on days 1, 8, and 15. Patients then receive vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51 ID and SC on days 29, 50, 71, 92, 113, and 134.
- Arm IV: Patients receive vaccine therapy as in arm III and imiquimod as in arm II.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 and 5 weeks and then at disease progression.
PROJECTED ACCRUAL: A maximum of 26 patients (approximately 6 per treatment arm) will be accrued for this study within approximately 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118313
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Craig L. Slingluff, MD||University of Virginia|