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Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma
This study is currently recruiting participants.
Verified by Washington University School of Medicine, August 2008
Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00683670
  Purpose

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.


Condition Intervention Phase
Melanoma
 Drug: cyclophosphamide
Biological: Mature dendritic cell vaccine
 Phase I
Phase II

MedlinePlus related topics: Melanoma
Drug Information available for: Cyclophosphamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To determine the immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay. [ Time Frame: tumor response ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the time to progression [ Time Frame: disease progression ] [ Designated as safety issue: No ]
  • To assess regulatory T cell depletion after cyclophosphamide administration. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • To perform exploratory biomarker analysis of accessible tumors [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • To determine the safety and side effect profile of mDC administered to patients given after a single dose of cyclophosphamide. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: August 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
mature dendritic cell vaccine and cyclophosphamide
Drug: cyclophosphamide
cyclophosphamide 300 mg/m2 IV over 1 hour on Day minus 3 of first dose of vaccine
Biological: Mature dendritic cell vaccine
Mature dendritic 15 million/peptide, 60 million total IV over 30 minutes (first dose)
Biological: Mature dendritic cell vaccine
mature dendritic cell booster dose X5 (q3 weeks) (5 million/peptide, 20 million total)

Detailed Description:

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will be given cyclophosphamide 300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells. All patients will receive mature DC for each dose of vaccine. For each dose all patients will receive autologous dendritic cells pulsed with 3 melanoma peptides (gp100 antigen) and one control (CMV) peptide. All patients will receive booster doses with mature DC. The DC vaccine will be given intravenously every three weeks for a total of six vaccine doses. Peripheral blood (16 ml) will be taken weekly to monitor the immune response to each peptide by tetramer assay. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Restaging is performed after three and six vaccine doses. Patients with stable disease or better (partial response/complete response) after six doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable stage III and stage IV M1a/M1b melanoma
  • Age > 18 years
  • Life expectancy > 4 months
  • ECOG performance status 0-2
  • HLA-A2 positive
  • gp100 expression in primary lesion or metastasis
  • At least 28 days from prior treatment (including adjuvant interferon)
  • Required initial laboratory values (submitted within 14 days prior to registration):

WBC >3,000/mm3 Platelets >75,000/mm3 Serum Bilirubin < 2.0 mg/dl Serum Creatinine < 2.0 mg/dl

Exclusion Criteria:

  • Prior treatment with cytotoxic chemotherapy
  • Active untreated CNS metastasis
  • Active infection
  • Prior malignancy (except non-melanoma skin cancer) within 3 years
  • Pregnant or nursing
  • Concurrent treatment with corticosteroids
  • Inability to provide adequate informed consent
  • Patients with known allergy to eggs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683670

Contacts
Contact: Gerald P Linette, M.D., Ph.D. 314-362-5677 glinette@dom.wustl.edu

Locations
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Gerald Linette, M.D., Ph.D.     314-362-5677     glinette@dom.wustl.edu    
Sub-Investigator: Benjamin Tan, M.D.            
Sub-Investigator: Beatriz M. Carreno, Ph.D.            
Sub-Investigator: Lynn A. Carreno, Ph.D.            
Sub-Investigator: George Despotis, M.D.            
Sub-Investigator: Kathryn Trinkaus, Ph.D.            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Gerald P. Linette, M.D., Ph.D. Washington Univerisity
  More Information

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Responsible Party: Washington University ( Gerald Linette, M.D., Ph.D. )
Study ID Numbers: 07-0652
Study First Received: May 19, 2008
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00683670  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
 Cyclophosphamide
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
 Neoplasms
Therapeutic Uses
Myeloablative Agonists
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on February 12, 2009



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