Clinical Trial Details
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NCT00880061 : An Open Label Dose Escalation Safety Study of Convection-Enhanced Delivery of IL13-PE38QQR in Patients With Progressive Pediatric Diffuse Infiltrating Brainstem Glioma and Supratentorial High-grade Glioma
PhasePhase 1
AgesMin: N/A Max: 17 Years

- Age less than 18 years

- Diagnosis: recurrent or progressive:


2. HGG

- Patients undergoing surgical resection must have measurable/evaluable disease prior
to study entry.

- Histopathologic Diagnosis

1. A histopathologic diagnosis is not required for patients with DIPG but a biopsy
may be recommended if the patient has an atypical presentation or atypical
findings on MR-imaging.

2. Histopathologic confirmation for patients with HGG is required. If necrosis is
suspected based on MR-imaging and Nuclear Medicine scans, biopsy or surgical
resection for confirmation of disease progression may be required.

- Prior Therapy

1. Patients must have received at least standard doses of radiation (i.e., greater
than 54 Gy).

2. Surgery/biopsy - Patients must be more than 2 weeks from any neurosurgical
procedure and cleared by the Principal Investigator before undergoing CED.

3. Radiation - Patients must be more than 4 weeks from last fraction of radiation
to the target site

4. Chemotherapy - Patients must not be on concurrent chemotherapy. The last dose
of chemotherapy must be greater than 2 weeks prior to CED and the patient must
have recovered from any toxic effects of prior therapy (to less than Grade 2 or

5. Biologic therapy - Patients must be greater than 7 days from biologic therapy.

6. Investigational therapy - Patients must be greater than 30 days from any
investigational therapy.

- Patients must be healthy enough to tolerate surgery and general anesthesia in the
opinion of the primary investigator. This includes, but is not limited to:

1. Adequate baseline organ function, including an age-adjusted normal serum
creatinine OR a creatinine clearance greater or equal to 60 mL/min/1.73m(2),
total bilirubin less than 2 times the upper limit of normal (ULN) and direct
bilirubin within normal limits. Patients with elevated SGPT (up to 5 times ULN)
will be eligible if the elevation is attributed to steroid treatment.

2. If neurological deficits are present, they must be stable for at least 1 week
prior to registration.

- Patients must be able to undergo MR-imaging with gadolinium-based contrast
administration (e.g. no ferrous-containing implants, no pacemakers, no allergy to
contrast, etc).

- All patients or their legal guardians must sign a document of informed consent
indicating their understanding of the investigational nature and the potential risks
associated with this study. When appropriate, pediatric patients will be included in
all discussions in order to obtain verbal and written assent.


- Patients with an uncorrectable bleeding disorder

- Patients with multifocal or leptomeningeal disease

- Patients with signs of impending herniation or an acute intratumoral hemorrhage

- Patients on concurrent chemotherapy or biologic therapy for the treatment of their

- Patients who are pregnant or breastfeeding, because of unknown effects of the study
agent, the strong magnetic fields and Gadolinium containing contrast agents on the
fetus; patients of child-bearing potential must be willing to practice an effective
form of birth control, including abstinence, hormone therapy, intrauterine device, 2
barrier methods.
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