Status:
COMPLETED
Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine
Lead Sponsor:
Dr. Nina Bhardwaj
Collaborating Sponsors:
Cancer Research Institute, New York City
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
In this study, we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00124124
Start Date
July 1 2005
End Date
April 1 2009
Last Update
February 13 2015
Active Locations (1)
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1
NYU Clinical Cancer Center
New York, New York, United States, 10016