Back to resultsComparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KLH; Peptides; Dendritic Cells
KLH, peptides plus Montanide
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility 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.
Sites / Locations
- NYU Clinical Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
KLH and peptide pulsed DCs
KLH, peptides plus Montanide
Outcomes
Primary Outcome Measures
Immunology
Secondary Outcome Measures
Safety
Full Information
NCT ID
NCT00124124
First Posted
July 25, 2005
Last Updated
February 11, 2015
Sponsor
Dr. Nina Bhardwaj
Collaborators
Cancer Research Institute, New York City
1. Study Identification
Unique Protocol Identification Number
NCT00124124
Brief Title
Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine
Official Title
A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Nina Bhardwaj
Collaborators
Cancer Research Institute, New York City
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
KLH and peptide pulsed DCs
Arm Title
2
Arm Type
Experimental
Arm Description
KLH, peptides plus Montanide
Intervention Type
Drug
Intervention Name(s)
KLH; Peptides; Dendritic Cells
Intervention Description
Upon entry into the study, patients randomized to the dendritic cell arm will undergo a complete baseline evaluation and leukapheresis 0.5 to 3 x 106 DCs per peptide antigen (total not to exceed 18 x 106 cells) will be administered intradermally as per injection SOP. They will receive up to 3 booster DC injections (total not to exceed 18 x 10 6 cells per injection) at monthly intervals for a total of 4 injections. The booster injections will not contain KLH, as our volunteer studies have shown that priming occurs following a single injection of DCs
Intervention Type
Drug
Intervention Name(s)
KLH, peptides plus Montanide
Intervention Description
Patients randomized to the Montanide arm will also undergo complete baseline evaluation but not leukapheresis. The peptides will be mixed with the adjuvant, Montanide, and administered subcutaneously at a dose of 100 microgram of each peptide +100 microgram KLH mixed with an equal volume of Montanide. They will receive up to 3 booster injections at monthly intervals for a total of 4 injections. The booster injections will not contain KLH.
Primary Outcome Measure Information:
Title
Immunology
Time Frame
Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens
Secondary Outcome Measure Information:
Title
Safety
Time Frame
Post drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Adams, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nina Bhardwaj, MD, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine
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