©2022 Stanford Medicine
Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas
Not Recruiting
Trial ID: NCT01514201
Purpose
This phase I/II trial studies the side effects and the best dose of veliparib when given
together with radiation therapy and temozolomide and to see how well they work in treating
younger patients newly diagnosed with diffuse pontine gliomas. Veliparib may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses
high-energy x rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide,
work in different ways to stop the growth of tumor cells either by killing the cells or by
stopping them from dividing. Giving veliparib with radiation therapy and temozolomide may
kill more tumor cells.
Official Title
A Phase I/II Study of ABT-888, An Oral Poly(ADP-ribose) Polymerase Inhibitor, and Concurrent Radiation Therapy, Followed by ABT-888 and Temozolomide, in Children With Newly Diagnosed Diffuse Pontine Gliomas (DIPG)
Stanford Investigator(s)
Paul Graham Fisher, MD
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Eligibility
Inclusion Criteria:
- Patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs), defined as
tumors with a pontine epicenter and diffuse intrinsic involvement of the pons, are
eligible without histologic confirmation; patients with brainstem tumors that do not
meet these criteria or not considered to be typical intrinsic pontine gliomas will
only be eligible if the tumors are biopsied and proven to be an anaplastic
astrocytoma, glioblastoma multiforme, gliosarcoma, anaplastic mixed glioma, or
fibrillary astrocytoma
- Patients with juvenile pilocytic astrocytoma, pilomyxoid astrocytoma, fibrillary
astrocytoma, gangliogliomas, or other mixed gliomas without anaplasia are not
eligible;
- Patients with disseminated disease are not eligible, and magnetic resonance
imaging (MRI) of spine must be performed if disseminated disease is suspected by
the treating physician
- Patient must be able to swallow oral medications to be eligible for study enrollment
- Karnofsky >= 50% for patients > 16 years of age or Lansky >= 50% for patients =< 16
years of age; 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
- Patients must have not received any prior therapy other than surgery and/or steroids
- Absolute neutrophil count >= 1,000/mm^3
- Platelets >= 100,000/mm^3 (unsupported)
- Hemoglobin >= 10 g/dL (unsupported)
- Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =< 5 x
institutional upper limit of normal for age
- Albumin >= 2 g/dL
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- 0.6 mg/dL (1 to < 2 years of age)
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)
- 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
- Patients of childbearing or child-fathering potential must be willing to use a
medically acceptable form of birth control, which includes abstinence, while being
treated on this study
- Signed informed consent according to institutional guidelines must be obtained;
assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
- Patients with any clinically significant unrelated systemic illness (serious
infections or significant cardiac, pulmonary, hepatic or other organ dysfunction),
that would compromise the patient's ability to tolerate protocol therapy or would
likely interfere with the study procedures or results
- Patients with inability to return for follow-up visits or obtain follow-up studies
required to assess toxicity to therapy
- Patients with active seizures or a history of seizure are not eligible for study
entry, with the exception of patients with documented febrile seizure
Intervention(s):
drug: veliparib
drug: temozolomide
radiation: 3-dimensional conformal radiation therapy
radiation: intensity-modulated radiation therapy
other: pharmacological study
other: laboratory biomarker analysis
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs