Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine
Phase 1
Completed
- Conditions
- Melanoma
- Interventions
- Drug: KLH; Peptides; Dendritic CellsDrug: KLH, peptides plus Montanide
- Registration Number
- NCT00124124
- Lead Sponsor
- Dr. Nina Bhardwaj
- 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 2 vaccine adjuvants in their efficacy to induce immune responses.
- 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 but at high risk for recurrence. This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 KLH; Peptides; Dendritic Cells KLH and peptide pulsed DCs 2 KLH, peptides plus Montanide KLH, peptides plus Montanide
- Primary Outcome Measures
Name Time Method Immunology Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens
- Secondary Outcome Measures
Name Time Method Safety Post drug administration
Trial Locations
- Locations (1)
NYU Clinical Cancer Center
🇺🇸New York, New York, United States