At a glance
ClinicalIndex Comparison Record- ✓Measurable metastatic (stage IV) or locally advanced (stage III) cutaneous melanoma
- ✓Expected survival greater than 3 months
- ✓ECOG performance status 0 or 1
- ✓Pathologic confirmation of cutaneous melanoma with slides reviewed at NIH
- ✕Non-cutaneous melanoma (ocular or mucosal)
- ✕Any prior therapy within 4 weeks except surgery
- ✕Active systemic infections, coagulation disorders, autoimmune disease, or major medical illnesses
- ✕Significant psychiatric disease preventing informed consent or making immunotherapy unsafe
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma
In Brief
A Phase 3 clinical trial evaluating Aldesleukin, gp100 Antigen, and 4 other interventions for Recurrent Melanoma and 4 related conditions. Completed, enrolled 185 participants across 19 sites.
Detailed Summary
This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma.
Study Details
Timeline
Interventions
Given IV
Given SC
Given SC
Ancillary studies
Ancillary studies
Correlative studies