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

D

Dr. Nina Bhardwaj

Status and phase

Completed
Phase 1

Conditions

Melanoma

Treatments

Drug: KLH; Peptides; Dendritic Cells
Drug: KLH, peptides plus Montanide

Study type

Interventional

Funder types

Other

Identifiers

NCT00124124
NYU 02-10

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

1
Experimental group
Description:
KLH and peptide pulsed DCs
Treatment:
Drug: KLH; Peptides; Dendritic Cells
2
Experimental group
Description:
KLH, peptides plus Montanide
Treatment:
Drug: KLH, peptides plus Montanide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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