Vaccine Therapy in Treating Patients With Metastatic Melanoma

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

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Study Overview

• Status: Completed
• Conditions: Intraocular Melanoma; Melanoma (Skin)
• Intervention / Treatment: Biological: tyrosinase peptide; Biological: therapeutic autologous dendritic cells; Biological: MART-1 antigen; Biological: gp100:209-217(210M) peptide vaccine

Detailed Description

OBJECTIVES:

Primary

• 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 cocktail.

Secondary

• 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 progression.

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089-9181
      • USC/Norris Comprehensive Cancer Center and Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0942
      • University of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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) peptides
• No concurrent steroid therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Time to progression
Progression-free survival
Overall survival

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Jeffrey S. Weber, MD, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: June 7, 2006
• First Submitted That Met QC Criteria: June 7, 2006
• First Posted (Estimate): June 8, 2006

Study Record Updates

• Last Update Posted (Estimate): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: recurrent melanoma; stage IV melanoma; ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; iris melanoma; recurrent intraocular melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 10M-03-1; LAC-USC-10M-03-1; NCI-6262; LAC-USC-033307; CDR0000480137 (Registry Identifier: PDQ (Physician Data Query)); NCI-2009-00050 (Registry Identifier: CTRP (Clinical Trials Reporting System))