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A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

Phase 2
18 Years
Open (Enrolling)
Glioblastoma Multiforme

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Trial Information

A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor-specific Cytotoxic T-cell Response

Outcome Description:

MRI & pheresis post vaccine

Outcome Time Frame:

Day 42

Safety Issue:


Principal Investigator

Camilo E. Fadul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

December 2013

Related Keywords:

  • Glioblastoma Multiforme
  • immunotherapy
  • cancer vaccine
  • glioblastoma multiforme
  • Glioblastoma



Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756