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.]

NCT03334305 : Adoptive Cellular Therapy in Pediatric Patients With High-grade Gliomas
PhasePhase 1
AgesMin: 3 Years Max: 21 Years
Eligibility
Screening Eligibility:

- Patients with histologically confirmed WHO Grade III or IV malignant glioma

- Scheduled for definitive surgical resection of suspected HGG (biopsy only subjects are
not eligible for this study)

Post-Surgical Resection Eligibility

- Histologically confirmed WHO Grade III or IV malignant glioma

- Residual post-surgical disease burden < 3 cm as defined by longest perpendicular
diameter of contrast enhancing tumor on post-operative MRI Karnofsky Performance
Status (KPS) of > 60% (KPS for > 16 years of age) or Lansky performance Score (LPS) of
= 60 (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 for at least 3 days); Hemoglobin > 8 g/dL (may be supported)

- 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.

- Signed informed consent according to institutional guidelines.

- Patient or patient guardian consent to PBSC harvest following registration.

- Subjects of childbearing or child-fathering potential must be willing to use medically
acceptable forms of birth control while being treated on this study.

- Subjects with post-surgical neurological deficits should have deficits that are stable
for a minimum of 1 week prior to registration.

Prior to 1st Vaccine

- Off corticosteroids or weaning to a minimal/stable dose of replacement steroids = 4
mg/day within 1 week of scheduled DC vaccination.

Exclusion Criteria:

- HGG biopsy only subjects are not eligible for this study

- Midline unresectable tumors

- Gliomatosis Cerebri

- Residual post-surgical disease burden > 3 cm as defined by longest perpendicular
diameter of contrast enhancing tumor on MRI.

- 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.

- Subjects with significant renal, cardiac (congestive cardiac failure, myocardial
infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.

- Subjects who require corticosteroids above physiologic doses (>4mg/day or equivalent
dexamethasone).

- Severe or unstable concurrent medical conditions.

- Prior allergic reaction to TMZ, GM-CSF, or Td

- Subjects who are unwilling or unable to receive treatment and undergo follow-up
evaluations at the enrolled Sunshine Project Consortium treatment site.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03334305      |      Link to official Clinicaltrials.gov listing
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