Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

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. Identifier: NCT00323115
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : September 26, 2012
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:
Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will be administered after three vaccinations for one year or until progression of disease.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Biological: Autologous Dendritic Cell Drug: Temozolomide Procedure: Radiotherapy Biological: Dendritic Cell Vaccine Phase 2

Detailed Description:
Two to six weeks after surgery, patients with newly diagnosed glioblastoma multiforme (GBM) will undergo a six-week course of radiotherapy with concurrent chemotherapy (temozolomide). Between three and seven weeks after completing radiotherapy/chemotherapy, patients will undergo leukapheresis to collect white blood cells. These cells will be grown into dendritic cells, and cultured with tumor cells from the individual patient. Vaccinations will be given every two weeks for a total of three vaccinations. Four weeks after the third vaccination patients will resume chemotherapy for one year or until disease progression.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme
Study Start Date : May 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vaccine Biological: Autologous Dendritic Cell
Vaccine given by cervical lymph node injection 3 times every other week

Drug: Temozolomide
Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC

Procedure: Radiotherapy
RT is standard of care (SOC) post surgery

Biological: Dendritic Cell Vaccine
Vaccine given cervical lymphnode injection 3 times every other week

Primary Outcome Measures :
  1. Tumor-specific Cytotoxic T-cell Response [ Time Frame: Day 42 ]
    MRI & pheresis post vaccine

Secondary Outcome Measures :
  1. Feasibility and Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination [ Time Frame: Pheresis ]
  2. Progression Free Survival (PFS)and Overall Survival (OS) Comparison to Prognostic Matched Historical Controls [ Time Frame: From Enrollment - March 2011 ]
    PFS will be assessed for each patient as the time from surgery until the patient reaches objective disease progression by MRI, defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of contrast enhancement of any lesion or any new enhancing tumor on MRI or CT scans.

  3. Immunological Parameters With PFS vs Overall Survival [ Time Frame: Evaluable patients for immunologic parameters are those who have completed 3 vaccines ]
  4. Radiological Response When There is Residual Enhancing Tumor at Baseline MRI [ Time Frame: MRI post vaccine ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven GBM with central pathology review at Dartmouth-Hitchcock Medical Center (DHMC)
  • Tumor specimen obtained at the time of surgery adequate for vaccination
  • 18 years of age or older
  • Karnofsky Performance Status 60% or greater
  • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 9th/L
  • Platelets greater than or equal to 100 x 10 9th/L
  • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) less than or equal to 5 times the upper limits of normal (ULN)
  • Total bilirubin less than or equal to 1.5 times ULN
  • Serum creatinine less than or equal to 1.5 times ULN, OR estimated creatinine clearance greater than or equal to 60 mL/min
  • No known immunosuppression other than chemo-related
  • Negative HIV serologies
  • No evidence of acute or chronic hepatitis on standard hepatitis C and B screening tests
  • No chemotherapy within four weeks prior to leukapheresis
  • Radiotherapy at outside institution is permitted if tissue was obtained at time of surgery at DHMC and patient is willing to follow-up per protocol
  • Off steroids for at least two weeks before leukapheresis
  • No second malignancies except non-melanoma skin cancer, and non-invasive cancer such at cervical CIS, superficial bladder cancer or breast CIS
  • Negative serum or urine pregnancy test for women of childbearing potential
  • No serious uncontrolled medical disorder or active infection
  • All patients must give informed consent
  • No history of clinical evidence of active autoimmune disease

Exclusion Criteria:

  • Invasive cancers in the past 5 years
  • Rheumatologic/autoimmune disease
  • Pregnancy or unwillingness to remain on acceptable form of birth control during study
  • Major cardiac, pulmonary, or other systemic disease; viral hepatitis; HIV infection

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 identifier (NCT number): NCT00323115

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Principal Investigator: Camilo E. Fadul, MD Dartmouth-Hitchcock Medical Center

Publications of Results:
Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00323115     History of Changes
Other Study ID Numbers: D0536
First Posted: May 9, 2006    Key Record Dates
Results First Posted: September 26, 2012
Last Update Posted: November 2, 2015
Last Verified: June 2014

Keywords provided by Dartmouth-Hitchcock Medical Center:
cancer vaccine
glioblastoma multiforme

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents