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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124124
• Other study ID #: NYU 02-10
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2005
• Last updated: February 11, 2015
• Start date: July 2005
• Est. completion date: April 2009

Study information

• Verified date: February 2015
• Source: Bhardwaj, Nina, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00045383

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	NYU Clinical Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Nina Bhardwaj	Cancer Research Institute, New York City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunology		Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens	No
Secondary	Safety		Post drug administration	Yes