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Vaccine Therapy in Treating Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334776
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : May 21, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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Brief Summary:

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 or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Overall survival
  2. Progression-free survival
  3. Time to progression
  4. Toxicity

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334776


Locations
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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
National Cancer Institute (NCI)
Investigators
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Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00334776    
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) )
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
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:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas