At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed stage III or IV melanoma
- ✓Tumor cells positive for gp100 antigen and/or tyrosinase
- ✓HLA type A1, A2, or A3
- ✓Measurable disease
- ✕Known or suspected allergy to any component of the vaccine
- ✕New York Heart Association class II, III, or IV heart disease
- ✕Medical condition that would preclude study participation
- ✕Concurrent chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial for the Evaluation of the Efficacy of Vaccination With Synthetic Melanoma Peptides Either Pulsed on Dendritic Cells, or Administered With GM-CSF-in-Adjuvant, Plus Administration of Sustemic IL-2, in Patients With Advanced Melanoma.
In Brief
A Phase 2 clinical trial evaluating aldesleukin, gp100 antigen, and 4 other interventions for Melanoma (Skin). Completed, enrolled 40 participants across 1 site.
Detailed Summary
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma.
Study Details
Timeline
Interventions
Systemic subcutaneous delivery of low-dose IL-2.