Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas

Not Recruiting

Trial ID: NCT01514201


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
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


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

      - 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


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

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