Status:
TERMINATED
Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Accelerate Brain Cancer Cure
Lyla Nsouli Foundation
Conditions:
Diffuse Intrinsic Pontine Glioma (DIPG)
Brain Stem Glioma
Eligibility:
All Genders
3-30 years
Phase:
PHASE1
Brief Summary
The standard of care for children with DIPG includes focal radiotherapy (RT) but outcomes have remained dismal despite this treatment. The addition of oral Temozolomide (TMZ) concurrently with RT foll...
Detailed Description
The standard of care for children with DIPG includes external beam focal radiotherapy (RT) but outcomes have remained dismal despite this treatment. The addition of oral Temozolomide (TMZ) concurrentl...
Eligibility Criteria
Inclusion
- Initial Screening
- Radiologically confirmed DIPG or other diffuse intrinsic brain stem glioma (Grade III or IV).
- Patient and/or parents/guardian willing to consent to biopsy for obtaining tumor material for confirmatory diagnosis and/or tumor RNA extraction and amplification.
- Biopsy confirmation of any grade of glioma (for patients with classic DIPG on neuroimaging or at least grade III glioma in case of other diffuse intrinsic brain stem gliomas)
- Karnofsky Performance Status (KPS) of \> 50% (KPS for \> 16 years of age) or Lansky performance Score (LPS) of ≥ 50 (LPS for ≤ 16 years of age) assessed within 2 weeks prior to registration;
- Bone Marrow;
- ANC (absolute neutrophil count) ≥ 1000/µl (unsupported)
- Platelets ≥ 100,000/µl (unsupported)
- Hemoglobin \> 8 g/dL (can be transfused)
- Renal;
- Serum creatinine ≤ upper limit of institutional normal
- Hepatic;
- Bilirubin ≤ 1.5 times upper limit of institutional normal for age
- SGPT (ALT) ≤ 3 times upper limit of institutional normal for age
- SGOT (AST) ≤ 3 times upper limit of institutional normal for age
- Patients of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control while being treated on this study.
- Signed informed consent according to institutional guidelines.
- Post Biopsy
- Patients with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration;
- Pathologic diagnosis of glioma on tumor biopsy.
Exclusion
- Patients with severe dysphagia, obtundation, or tetraplegia (poor risks for anesthesia and biopsy procedure);
- Absence of tumor on biopsy specimen;
- Pregnant or need to breast feed during the study period (Negative serum pregnancy test required)
- Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection;
- Patients with significant renal, cardiac, pulmonary, hepatic or other organ dysfunction;
- Severe or unstable concurrent medical conditions;
- Patients who require corticosteroids above physiologic doses (\>4 mg/day dexamethasone) after chemoradiotherapy;
- Patients scheduled to receive any other concurrent anticancer or investigational drug therapy;
- Prior allergic reaction to TMZ, GM-CSF, or Td;
- Patients who are unwilling or unable to receive treatment and undergo follow-up evaluations at University of Florida;
- Patient and/or parent/guardian demonstrating an inability to comply with the study and/or follow-up procedures.
Key Trial Info
Start Date :
July 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03396575
Start Date
July 17 2018
End Date
March 20 2025
Last Update
October 29 2025
Active Locations (1)
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1
UF Health Shands Children's Hospital
Gainesville, Florida, United States, 32610