Clinical Trial Details
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NCT02343224 : Phase II Pegylated Interferon
PhasePhase 2
AgesMin: 3 Years Max: 18 Years
Inclusion Criteria:

- Patients must be older than 3 years and less than 18 years of age at the time of

- Patients with neurofibromatosis are eligible

- Histologic confirmation is not required for this if the patient has NF-1 with MRI
findings consistent with optic pathway glioma or JPA. Any other tumors will need
histological confirmation, either at the time of diagnosis or at the time of
recurrence. The histological diagnosis includes WHO grade I JPA

- Patients must have measurable residual disease, defined as tumor that is measurable in
two or three perpendicular diameters on MRI. For a lesion to be considered measurable,
it must be at least twice the slice thickness on MRI (i.e visible on more than one

- All patients must have a brain MRI with and without contrast (gadolinium) within 30
days prior to study enrollment. All patients with history of spinal or leptomeningeal
disease and those patients with symptoms suspicious of spinal disease, must have a
spine MRI with contrast ( gadollinium) performed within 30 days prior to study
enrollment. Lumbar Puncture is necessary if there is evidence of tumor dissemination
on the MRI of spine

- Performance Level: Karnofsky >or equal to 50% for patients > 10 years of age or Lansky
> or equal to 50 for patients < 10 years of age

- Patients must have recovered (to CTC v.4.0 = Grade 1 unless indicated below) from the
acute toxic effects of all prior chemotherapy, immunotherapy prior to entering this
study, with the exception of alopecia, weight changes and Grade I or II lymphopenia

- At least 7 days must have elapsed since the completion of therapy with other biologic
agents. For other biologic agents that have known adverse events occurring beyond 7
days after administration, this period must be extended beyond the time during which
adverse events are known to occur

- At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.
Specifically for bevacizumab 36 days after the last dose

- At least 3 weeks from the last surgical resection, prior to start study drug

- At least 42 days after the completion of any type of immunotherapy, e.g. tumor

- Patients must have had their last fraction of cranial or craniospinal Radiation = 24
months prior to study entry

- Adequate organ function

Exclusion Criteria:

- Patients who are receiving concurrent chemotherapy, or who are currently receiving
other investigational chemotherapeutic agents or concurrently receiving radiation

- Patients with a known hypersensitivity to interferon-alpha

- Prior use of Peg-intron or interferon

- Less than 2 years since completion of radiation therapy

- Pregnant or breast-feeding females are excluded

- Patients with clinically significant unrelated systemic illness

- Dental braces or prosthesis that interferes with MR imaging

- History of noncompliance to medical regimens

- Patients unwilling to or unable to comply with the protocol

- Patients with a positive history of Hepatitis B or Hepatitis C

- Patient with diagnosis of Diffuse Intrinsic Pontine Glioma
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