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A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma

Phase 2
16 Years
Not Enrolling
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma



- Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma
treated with an intradermally administered vaccine comprising autologous dendritic
cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine


- Determine immunologic response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo
with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and
tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin
(IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.

Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22,
and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically until disease

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of melanoma

- Metastatic disease

- The following melanoma subtypes are eligible:

- Unresectable, stage III-IV uveal melanoma

- Metastatic mucosal melanoma

- Measurable disease after attempted curative surgical therapy

- Tumor tissue must be available for immunohistochemical staining

- Positive for ≥ 1 of the following peptides:

- MART-1: 26-35 (27L)

- gp100: 209-217 (210M)

- Tyrosinase: 368-376 (370D)

- HLA-A *0201 positive by DNA polymerase chain reaction assay


- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

- Creatinine ≤ 2.0 mg/dL

- Bilirubin ≤ 2.0 mg/dL

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- No major systemic infections

- No coagulation disorders

- No major medical illness of the cardiovascular or respiratory system

- No myocardial infarction within the past 6 months

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- No know positivity for hepatitis B surface antigen or hepatitis C antibody

- No prior uveitis or autoimmune inflammatory eye disease

- No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer
unless patient was curatively treated > 5 years ago and has no detectable disease


- See Disease Characteristics

- No more than 1 prior cytotoxic chemotherapy agent or regimen

- Prior biologic or antiangiogenic therapies allowed

- More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant
therapy, or any other therapy for melanoma

- No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D)

- No concurrent steroid therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Jeffrey S. Weber, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2003

Completion Date:

June 2005

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • ciliary body and choroid melanoma, medium/large size
  • iris melanoma
  • recurrent intraocular melanoma
  • extraocular extension melanoma
  • Melanoma
  • Uveal Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804