At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed cutaneous, mucosal, or primary melanoma, Stage IIB-IV
- ✓Surgical resection or stereotactic radiosurgery for melanoma ≥1 week but ≤6 months ago with no clinical or radiological evidence of disease
- ✓HLA-A1, -A2, or -A3 positive AND HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
- ✓Must have ≥2 intact (undissected) axillary and/or inguinal lymph node basins
- ✕Ocular melanoma
- ✕Prior vaccination with any of the synthetic peptides used in this study
- ✕Autoimmune disorder with visceral involvement or requiring cytotoxic or immunosuppressive therapy
- ✕HIV positive
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants With Resected Melanoma
In Brief
A Phase 2 clinical trial evaluating incomplete Freund's adjuvant, melanoma helper peptide vaccine, and 3 other interventions for Melanoma (Skin). Completed, enrolled 170 participants across 3 sites.
Detailed Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma. PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Study Details
Timeline
Interventions
Given intradermally and subcutaneously
Given intradermally and subcutaneously
Given intradermally and subcutaneously
Given intradermally and subcutaneously
Given IV