Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity

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 Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: KLH; Peptides; Dendritic Cells; Drug: KLH, peptides plus Montanide

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Nyu Clinical Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; KLH and peptide pulsed DCs	Drug: KLH; Peptides; Dendritic Cells; 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
Experimental: 2; KLH, peptides plus Montanide	Drug: KLH, peptides plus Montanide; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunology	Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety	Post drug administration

Collaborators and Investigators

• Sponsor: Dr. Nina Bhardwaj
• Collaborators: Cancer Research Institute, New York City
• Investigators: Principal Investigator: Nina Bhardwaj, MD, PhD, NYU Langone Health; Study Director: Sylvia Adams, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: July 25, 2005
• First Submitted That Met QC Criteria: July 25, 2005
• First Posted (Estimate): July 27, 2005

Study Record Updates

• Last Update Posted (Estimate): February 13, 2015
• Last Update Submitted That Met QC Criteria: February 11, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Monatide (IMS 3015)
• Other Study ID Numbers: NYU 02-10