Expired Study
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New York, New York 10016


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

NYU 02-10


NCT ID:

NCT00124124


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bhardwaj, Nina, M.D.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sylvia Adams, MD
Study Director
New York University School of Medicine

Study Dates

Start Date:July 2005
Completion Date:April 2009
Completion Type:Actual
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:February 2015
Last Changed Date:February 11, 2015
First Received Date:July 25, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Immunology
Time Frame:Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety
Time Frame:Post drug administration
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:KLH; Peptides; Dendritic Cells
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
Arm Name:1
Intervention Type:Drug
Name:KLH, peptides plus Montanide
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.
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:KLH and peptide pulsed DCs
Study Arm Type:Experimental
Arm Name:2
Description:KLH, peptides plus Montanide

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dr. Nina Bhardwaj
Agency Class:Other
Agency Type:Collaborator
Agency Name:Cancer Research Institute - New York, NY 10006

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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