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NCT Number: NCT00124124

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYU Clinical Cancer Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KLH; Peptides; Dendritic Cells

Drug

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

KLH, peptides plus Montanide

Drug

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 outcomes

  1. Immunology

    Time frame: Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens

Secondary outcomes

  1. Safety

    Time frame: Post drug administration

Sponsors and collaborators

Lead sponsor

Dr. Nina Bhardwaj

Indiv

Collaborators

  • Cancer Research Institute, New York City

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jul 27, 2005
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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