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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Immunology

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Sylvia Adams, MD

Investigator Role:

Study Director

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

NYU 02-10

NCT ID:

NCT00124124

Start Date:

July 2005

Completion Date:

December 2013

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

NYU Clinical Cancer CenterNew York, New York  10016