Clinical Trial Details
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NCT03086616 : CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With DIPG
PhasePhase 1
AgesMin: 3 Years Max: N/A
Inclusion Criteria:

- Patients with newly diagnosed DIPG by MRI; defined as patients with a pontine location
and diffuse involvement of at least 2/3 of the pons are eligible without histologic
diagnosis. For lesions with typical imaging features, biopsy is neither encouraged nor
required for eligibility. Tumors that are biopsied will be eligible if proven to be
supportive of the diagnosis of a DIPG. Consensus of diagnosis by the study team must
be met.

- Treatment must begin at a minimum of 4 weeks after but no later than 14 weeks of the
date of the completion of radiotherapy.

- Prior Chemotherapy: Patients should be at least 30 days from last chemotherapy dose
prior to start of CED infusion, with exception of antibody half-lives. For antibody
therapies, at least 3 half-lives of the antibody after last dose of monoclonal
antibody should have passed prior to CED infusion.

- Prior Radiation: Patients must have received prior treatment with focal radiotherapy
as part of initial treatment for DIPG and had their last dose at least 4 weeks prior
to and no later than 14 weeks from the first CED treatment with liposomal-irinotecan.
Standard focal radiation therapy will include 54 to 60 Gy by external beam
radiotherapy to the brainstem.

- Age = 3 years of age

- Karnofsky = 50 for patients > 16 years of age and Lansky = 50 for patients 16 years of
age and younger. Patients who are unable to walk because of paralysis, but who are up
in a wheelchair, will be considered ambulatory for the purpose of assessing the
performance score.

- Life expectancy of greater than 12 weeks measured from the date of completion of

- Corticosteroids: Patients who are receiving dexamethasone must be on a stable or
decreasing dose for at least 1 week prior to registration.

- Organ Function Requirements

- Adequate Bone Marrow Function Defined as:Peripheral absolute neutrophil count
(ANC) =1000/mm3 and platelet count = 100,000/mm3 (transfusion independent,
defined as not receiving platelet transfusions for at least 7 days prior to
enrollment) and normal coagulation defined as normal INR or per institutional

- Adequate Renal Function Defined as:

- Creatinine clearance or radioisotope GFR = 70mL/min/1.73 m2 or

- A serum creatinine based on age/gender as follows:

Age Maximum Serum Creatinine (mg/dL) Male Female 3 to < 6 years 0.8 0.8 6 to < 10 years 1 1
10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4

= 16 years 1.7 1.4

- Adequate Liver Function Defined as: Bilirubin (sum of conjugated + unconjugated) less
than or equal to 1.5 x upper limit of normal (ULN) for age and SGPT (ALT) less than or
equal to 110 U/L. and Serum albumin = 2 g/dL.

- Adequate Neurologic Function Defined as: Patients with seizure disorder may be
enrolled if on non-enzyme inducing anticonvulsants and well controlled.

- The effects of irinotecan liposome injection on the developing human fetus are
unknown. For this reason women of child-bearing potential and men must agree to
use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation and 4
months after completion of irinotecan liposome injection administration. Should a
woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients who are receiving any other investigational agents or other tumor-directed

- Patients with metastatic disease, including leptomeningeal or subarachnoid
disseminated disease.

- Patients with tumor morphology that predicts poor coverage of the majority of the
tumor. This will be determined by the study chairs. Patients with evidence of cystic
changes greater than 1 cm in diameter will be excluded. These subjects should be
discussed with the study chairs.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to irinotecan, topotecan, gadolinium, or lipids.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Female patients of childbearing potential must not be pregnant or breast-feeding.
Female patients of childbearing potential must have a negative serum or urine
pregnancy test within 7 days of registration.

- Patients with inability to return for follow-up visits or obtain follow-up studies
required to assess toxicity to therapy; telemedicine visits are acceptable.

- Patients with MRI or clinical evidence of uncontrolled tumor mass effect are excluded;
the assessment of mass effect should be made by the study chair(s) and study
neurosurgeon prior to any planned CED treatment.

- Patients with evidence of intra-tumoral hemorrhage > 5 mm maximal diameter. These
subjects should be discussed with the study chair.

- Patients with tumor morphology that predicts poor coverage of the majority of the
tumor including bilateral thalamic involvement, >30% of estimated tumor volume outside
the pons, or cysts that represent >50% of cross-sectional areas of the pons. Patients
with evidence of cystic changes greater than 1 cm in diameter will be excluded. These
subjects should be discussed with the study chair(s).

- Patients must not be on enzyme-inducing anticonvulsants or other drugs that might
interact with the cytochrome P450 enzyme system. If previously on an EIAED, patient
must be off for at least 10 days prior to CED infusion.

- Untreated symptomatic hydrocephalus determined by treating physician.
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