drugset / Trial / NCT02425306
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma
Phase 1/2
Terminated
48 enrolled
Craig L Slingluff, Jr
Cancer Research Institute, New York City · collabLudwig Institute for Cancer Research · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.
Timeline
- Start
- 2015-05-12
- Primary completion
- 2017-08-18
- Completion
- 2018-01-08
Outcome
Outcome not reported
Stopped (Enrollment): “Slow accrual to part 2 of the study. Accrual to part 1 is complete.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 6MHP | Vaccine | 200 ug | — |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | Oral |
| Subject | Hiltonol | Other / unclassified | 1 mg | — |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | — |