Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Nina Bhardwaj
• Collaborator: Cancer Research Institute, New York City

Criteria

Inclusion Criteria:

• Resected stage IIB, IIC, or stage III melanoma.

• Fully recovered from surgery

• Human leukocyte antigen (HLA) A*0201 positive.

• Age >18 years.

• Karnofsky performance status: >80% and normal labs.

Exclusion Criteria:

• Prior chemotherapy.

• Known chronic infection with HIV, hepatitis B or C.

• Patients with known autoimmune disease [e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)]. Patients with vitiligo are not excluded.

• Pregnant women.

• Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides).

• Patients who have known retinal or choroidal eye disease.

• Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible.

• Allergy to shellfish.