NCT00124124

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

July 25, 2005

Last Update Submit

February 11, 2015

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • Immunology

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

Secondary Outcomes (1)

  • Safety

    Post drug administration

Study Arms (2)

1

EXPERIMENTAL

KLH and peptide pulsed DCs

Drug: KLH; Peptides; Dendritic Cells

2

EXPERIMENTAL

KLH, peptides plus Montanide

Drug: KLH, peptides plus Montanide

Interventions

KLH; Peptides; Dendritic CellsDRUG

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

1
KLH, peptides plus MontanideDRUG

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

keyhole-limpet hemocyaninPeptidesMonatide (IMS 3015)

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Sylvia Adams, MD

    NYU Langone Health

    STUDY DIRECTOR

  • Nina Bhardwaj, MD, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Tumor Vaccine Program

Study Record Dates

First Submitted

July 25, 2005

First Posted

July 27, 2005

Study Start

July 1, 2005

Primary Completion

July 1, 2008

Study Completion

April 1, 2009

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

US(1)