A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity
18 Years
N/A
Both
Melanoma
Trial Information
A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Immunology
Outcome Time Frame:
Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens
Safety Issue:
No
Principal Investigator
Sylvia Adams, MD
Investigator Role:
Study Director
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
NYU 02-10
NCT ID:
NCT00124124
Start Date:
July 2005
Completion Date:
December 2013
Related Keywords:
- Melanoma
- Melanoma
Name | Location |
|---|---|
| NYU Clinical Cancer Center | New York, New York 10016 |
