Status:
TERMINATED
Imiquimod/Brain Tumor Initiating Cell (BTIC) Vaccine in Brain Stem Glioma
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Diffuse Intrinsic Pontine Glioma
Eligibility:
All Genders
3+ years
Phase:
PHASE1
Brief Summary
This is a pilot/feasibility study. The study design represents a modification of current standard of care for Diffuse Intrinsic Pontine Glioma (DIPG) (5580 cGY involved field radiation), with the fina...
Detailed Description
Vaccine will be produced by the University Of Minnesota Molecular and Cellular Therapeutics Facility using the established brain tumor initiating cell (BTIC) cell line GBM-6 as the antigen source. Vac...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 16 years or older patients with histologically confirmed glioblastoma multiforme (GBM) World Health Organization (WHO) grade III-IV with recurrent or progressive disease after standard therapy (enrollment plan 1).
- Age 3 years and older patients with diffuse intrinsic pontine glioma (DIPG) diagnosed by magnetic resonance imaging (MRI). Completion of standard radiation therapy (not to exceed 5580 cGy) with a post radiation therapy (RT) MRI that shows no disease progression when compared with pre-RT MRI. All patients must be treated with Intensity Modulated Radiation Therapy (IMRT) or an equivalent conformal technique. Patients from an outside institution who are referred after the start of radiation therapy may complete initial radiation therapy at their home institution as long as dosage guidelines are met and the total dose does not exceed 5580 cGy at the time of study registration (enrollment plan 2 and 3).
- all patients regardless of diagnosis must be clinically stable and off or on low dose (no more than 0.1 mg/kg/day, maximum of 4 mg/day dexamethasone) corticosteroid for at least 1 week prior to study enrollment.
- Exclusion Criteria:
- Pregnant or breast-feeding. Pregnancy testing will be performed on all menstruating females within 14 days prior to 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 chemotherapy, investigational agents or registration on another therapy based trial or received chemotherapy with radiation therapy
- History of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, ongoing pregnancy, transplant immunosuppression)
- Any isolated laboratory abnormality suggestive of a serious autoimmune disease
- Any conditions that could potentially alter immune function (AIDS, multiple sclerosis, diabetes, renal failure)
- Receiving ongoing treatment with immunosuppressive drugs, excluding those patients requiring dexamethasone for treatment of tumor-related edema
Exclusion
Key Trial Info
Start Date :
July 17 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01400672
Start Date
July 17 2012
End Date
October 8 2018
Last Update
March 18 2020
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455