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Phase I Study of Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Recurrent or Progressive Malignant Gliomas

Phase 1
Not Enrolling
Brain Tumor, Glioblastoma, Medulloblastoma, Ependymoma, Anaplastic Astrocytoma

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Trial Information

Phase I Study of Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Recurrent or Progressive Malignant Gliomas

Autologous DCs will be obtained from peripheral blood mononuclear cells (PBMCs) from each
patient by leukapheresis. An established BTSC line will be used as an allogeneic source of
tumor antigen. Approximately 4 weeks will be required after the leukapheresis for vaccine
production and the first vaccine administration.

Each patient will receive an injection of DCs at his/her assigned dose once every 2 weeks
during the first 8 weeks, followed by injections every 4 weeks for an additional 10
vaccinations. Imiquimod will be applied to the vaccination site just prior to and 24 hours
after each vaccine administration.

This study will use an accelerated dose escalation design (1 subject per level) until dose
limiting toxicity (DLT) is encountered, after which a traditional phase I design (3 subjects
per level) will be implemented. DLT is defined as grade 3 or greater treatment related
toxicity. A total of 6 patients will be treated at the maximum tolerated dose (MTD) or, in
the absence of DLT, at dose level 3.

Inclusion Criteria:

- Histologically confirmed brain tumors (glioblastoma multiforme, anaplastic
astrocytoma, medullo

- Age 0 through 17 years (pediatric subjects), and 18 years and above (adult subjects)

- Lansky score of ≥ 60 (0-15 years) or Karnofsky (16 years or older) performance score
of ≥ 60%

- Adequate organ function within 14 days of study registration including the following:

- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
(ANC) ≥ 1.0 x 10^9/L, platelets ≥100 x 10^9/L; hemoglobin ≥ 8 g/dL

- Hepatic: bilirubin ≤1.3 mg/dL or 0-22 mmol/L, aspartate transaminase (AST) and
alanine transaminase (ALT) < 3 x upper limit of normal (ULN)

- Renal: Normal serum creatinine for age (below) or creatinine clearance >60
ml/min/1.73 m^2.

- Sexually active women of child bearing potential must agree to use adequate
contraception (diaphragm, birth control pills, injections, intrauterine device [IUD],
surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration
of the vaccination period. Sexually active men must agree to use barrier
contraceptive for the duration of the vaccination period.

- Willingness to travel to participate in study if from outside local region.

- Voluntary written informed consent must be obtained from all patients (if of assent
age) and their parents or legal guardians before performance of any study-related
procedure not part of normal medical care, with the understanding that consent may be
withdrawn by the subject at any time without prejudice to future medical care.

Exclusion criteria:

- Pregnant or breast-feeding. Pregnancy testing will be performed on all menstruating
females within 14 days of study enrollment.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study

- Currently receiving any other investigational agents.

- History of immune system abnormalities such as hyperimmunity (e.g., autoimmune
diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS,
ongoing pregnancy, transplant immuno-suppression).

- Any conditions that could potentially alter immune function (e.g., AIDS, multiple
sclerosis, diabetes, renal failure).

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:

Maximum Tolerated Dose

Outcome Description:

To determine the safety and maximum tolerated dose (MTD) of dendritic cells (DCs) loaded with brain tumor stem cells (BTSCs) as a source of tumor antigen for immunotherapy in children and adults with recurrent GBM, ependymoma or medulloblastoma brain tumors. Toxicity is determined using the criteria established by the National Cancer Institute's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE).

Outcome Time Frame:

4 Weeks Post Vaccination

Safety Issue:


Principal Investigator

Christopher Moertel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

June 2012

Related Keywords:

  • Brain Tumor
  • Glioblastoma
  • Medulloblastoma
  • Ependymoma
  • Anaplastic Astrocytoma
  • Brain tumor
  • Immunotherapy
  • Glioma
  • Astrocytoma
  • Brain Neoplasms
  • Ependymoma
  • Glioblastoma
  • Medulloblastoma



Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455