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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cancer Research Institute - New York, NY 10006
Information provided by (Responsible Party):
Dr. Nina Bhardwaj, Bhardwaj, Nina, M.D.
ClinicalTrials.gov Identifier:
NCT00124124
First received: July 25, 2005
Last updated: December 12, 2012
Last verified: December 2012
  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.


Condition Intervention Phase
Melanoma
Drug: KLH; Peptides; Dendritic Cells
Drug: KLH, peptides plus Montanide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity

Resource links provided by NLM:


Further study details as provided by Bhardwaj, Nina, M.D.:

Primary Outcome Measures:
  • Immunology [ Time Frame: Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Post drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: July 2005
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124124

Locations
United States, New York
NYU Clinical Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
Dr. Nina Bhardwaj
Cancer Research Institute - New York, NY 10006
Investigators
Study Director: Sylvia Adams, MD New York University School of Medicine
Principal Investigator: Nina Bhardwaj, MD, PhD New York University School of Medicine
  More Information

No publications provided

Responsible Party: Dr. Nina Bhardwaj, Director, Tumor Vaccine Program, Bhardwaj, Nina, M.D.
ClinicalTrials.gov Identifier: NCT00124124     History of Changes
Obsolete Identifiers: NCT00045383
Other Study ID Numbers: NYU 02-10
Study First Received: July 25, 2005
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 26, 2014