Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine - Full Text View

Sponsor:	Bhardwaj, Nina, M.D.
Collaborator:	Cancer Research Institute
Information provided by:	Bhardwaj, Nina, M.D.
ClinicalTrials.gov Identifier:	NCT00124124

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 I

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:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

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 2010
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.

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

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

Bhardwaj, Nina, M.D.

Cancer Research Institute

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:	Nina Bhardwaj, MD, PhD, NYU Langone Medical Center
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:	February 17, 2010
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
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012