drugset / Trial / NCT01079741
Safety Study of Adjuvant Vaccine to Treat Melanoma Patients
Phase 1/2
Completed
34 enrolled
Nina Bhardwaj
Cancer Research Institute, New York City · collabLudwig Institute for Cancer Research · collabOncovir, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortality rate, even with initial optimal surgical resection. Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate. Immunotherapy has long been recognized as a potential therapy for melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease.
Timeline
- Start
- 2010-09
- Primary completion
- 2013-03-11
- Completion
- 2013-03-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hiltonol | Other / unclassified | 0.35 mg | Subcutaneous |
| Subject | Hiltonol | Other / unclassified | 1.4 mg | Subcutaneous |
| Subject | Montanide | Other / unclassified | 1.1 ml | — |
| Subject | NY-ESO-1 | Protein / enzyme biologic | 100 ug | Subcutaneous |