Clinical Trial Details
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NCT02015728 : Selecting Patient-Specific Biologically Targeted Therapy for Pediatric Patients With Refractory Or Recurrent Brain Tumors
AgesMin: 1 Month Max: 30 Years
Inclusion Criteria:

Patients must have histological confirmation of a brain tumor at diagnosis or relapse for
all tumors.

There must be documented progression or recurrence of disease by MRI imaging or CSF
studies since completion of last tumor-directed medical therapy. Patients may have had
surgical resection or radiation of tumor, and need not have measurable or evaluable
disease at study entry.

Patient's current disease state must be one for which there is no known curative therapy.

Age greater than 1 month and less than 30 years at the time of enrollment.

BSA greater than 0.3 m2 at the time of enrollment.

Karnofsky >/= 50% for patients > 16 years of age, and Lansky >/= 50% for patients years of age.

- Neurologic deficits in patients with CNS tumors must have been relatively stable for
a minimum of 7 days.

- 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.

Adequate bone marrow function including:

- ANC > 750

- Platelet count > 100,000/uL without platelet transfusion within the past 7 days

Adequate renal function defined as creatinine within normal range for age or calculated
GFR > 100 ml/min/1.73 m2.

Adequate liver function defined as Bilirubin < 1.5 x upper limit of normal and ALT < 2.5 x
upper limit of normal.

Adequate CNS function:

- Patients with known seizure disorder must have seizures adequately controlled with
non-enzyme inducing antiepileptic medications

- No increase in steroid dose within the past 7 days.

Patients must have fully recovered from the acute toxic effects of all prior chemotherapy,
immunotherapy, or radiotherapy:

- Myelosuppressive chemotherapy: Must not have received within 3 weeks of entry onto
this study (6 weeks if prior nitrosourea).

- Hematopoietic growth factors: At least 7 days since the completion of therapy with a
growth factor, 14 days for longacting (e.g. PEG-filgrastim)

- Biologic (anti-neoplastic agent): At least 7 days or 3 half-lives (whichever is
longer) since the completion of therapy with a biologic agent.

- Radiation therapy: ? 12 weeks must have elapsed from craniospinal radiation; ? 2
weeks must have elapsed from focal radiation.

- Surgery: > 3 weeks from major surgery. If recent craniotomy, adequate wound healing
must be determined by neurosurgical team prior to starting study therapy.

- Autologous Stem Cell Transplant or Rescue: No evidence of active graft vs. host
disease and ? 4 weeks must have elapsed.

All patients and/or a legal guardian must sign institutionally approved written informed
consent document.

Exclusion Criteria:

Patients who are breastfeeding, pregnant or refuse to use an effective form of birth
control are excluded. Abstinence is considered an effective form of birth control.

Patients with uncontrolled infection are excluded.

Patients with known bleeding disorders or more than punctate intratumoral hemorrhage are

Patients receiving other anti-neoplastic agents are excluded.

Patients on enzyme-inducing anticonvulsive agents are excluded.

Patients requiring strong CYP3A4 inducers or inhibitors are excluded.

Patients requiring anticoagulation or with uncontrolled bleeding are excluded.

Patients on steroids for symptom management must be on a stable dose over the 7 days prior
to study enrollment.

Patients within 1 year of allogeneic stem cell transplant, patients with active GVHD or
requiring immunosuppression are excluded.
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