Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03396575 : Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)
PhasePhase 1
AgesMin: 3 Years Max: 21 Years
Eligibility
Inclusion Criteria:

Initial Screening

- Radiologically confirmed DIPG and patient and/or parents/guardian willing to consent
to biopsy;

- 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.

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 Criteria:

- 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03396575      |      Link to official Clinicaltrials.gov listing
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