drugset / Trial / NCT00580060
Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
Phase 0
Completed
20 enrolled
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.
Timeline
- Start
- 2003-12
- Primary completion
- 2011-06
- Completion
- 2011-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM-CSF DNA | Other / unclassified | 100 ug | Subcutaneous |
| Subject | GM-CSF DNA | Other / unclassified | 400 ug | Subcutaneous |
| Subject | GM-CSF DNA | Other / unclassified | 800 ug | Subcutaneous |
| Subject | NSC 683472 gp100: 209-217(210M) | Peptide | — | Subcutaneous |
| Subject | NSC 699048 Tyrosinase: 368-376(370D) | Peptide | — | Subcutaneous |