Status:
COMPLETED
Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Brain Tumor
Glioblastoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This is a single center Phase I study to determine the safety and maximum tolerated dose (MTD) of autologous dendritic cells (DCs) loaded with allogeneic brain tumor stem cells administered as a vacci...
Detailed Description
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. Appr...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 requirements.
- 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).
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01171469
Start Date
September 1 2010
End Date
June 1 2012
Last Update
December 2 2017
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455