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

Completed · Phase 1

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00124124

Run by

Dr. Nina Bhardwaj

People needed

50

Starts

2005-07-01

Expected to finish

2009-04-01

Last updated by the study team

2015-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NYU Clinical Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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