Vaccine Therapy in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00334776
First received: June 7, 2006
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Biological: MART-1 antigen
Biological: gp100:209-217(210M) peptide vaccine
Biological: therapeutic autologous dendritic cells
Biological: tyrosinase peptide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334776

Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Sponsors and Collaborators
University of Southern California
Investigators
Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California
  More Information

Additional Information:
No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00334776     History of Changes
Other Study ID Numbers: 10M-03-1, LAC-USC-10M-03-1, NCI-6262, LAC-USC-033307, CDR0000480137, NCI-2009-00050
Study First Received: June 7, 2006
Last Updated: May 19, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
recurrent melanoma
stage IV melanoma
ciliary body and choroid melanoma, medium/large size
iris melanoma
recurrent intraocular melanoma
extraocular extension melanoma

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 26, 2014