Trial Search Results

Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma

This phase II trial studies how well sunitinib malate works in treating younger patients with recurrent, refractory, or progressive malignant glioma or ependymoma. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Other: Diagnostic Laboratory Biomarker Analysis
  • Other: Pharmacological Study
  • Drug: Sunitinib Malate

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Patients must be diagnosed with ependymoma or high-grade glioma (World Health
   Organization [WHO] grade III/IV):

      - Stratum A: recurrent/progressive/refractory malignant glioma (i.e., anaplastic
      astrocytoma, glioblastoma multiforme [including giant cell and gliosarcoma
      types], anaplastic oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic
      ganglioglioma) within the brain with or without spinal cord disease

      - Stratum B: recurrent/progressive/refractory ependymoma (including ependymoma
      variants) within the brain with or without spinal cord disease

      - Patients with diffuse intrinsic pontine glioma are not eligible

   - A histological diagnosis from either the initial presentation or at the time of
   recurrence is required

   - Patients must have radiographically documented measurable disease in the brain,
   defined as at least one lesion that can be accurately measured in at least 2 planes

   - To document the degree of residual tumor, the following must be obtained:

      - All patients must have a brain MRI with and without gadolinium and a spine
      magnetic resonance imaging (MRI), if clinically indicated,with and without
      gadolinium, performed within 2 weeks prior to study enrollment

      - Patients with evidence of new central nervous system (CNS) hemorrhage of more
      than punctate size and/or more than 3 foci of punctate hemorrhage on baseline MRI
      obtained within 14 days prior to study enrollment are not eligible

   - Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 (use
   Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age)

      - Neurological deficits in patients must have been relatively stable for a minimum
      of 1 week prior to study enrollment; 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

   - Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL

   - Platelet count ≥ 75,000/μL (transfusion independent, defined as not receiving platelet
   transfusions within the 7-day period prior to enrollment)

   - Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)

   - Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min OR
   serum creatinine based on age/gender as follows:

      - 0.4 mg/dL (1 month to < 6 months of age)

      - 0.5 mg/dL (6 months to < 1 year of age)

      - 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)

   - Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

   - Serum glutamic oxaloacetic transaminase (SGOT/AST) and serum glutamic pyruvic
   transaminase (SGPT/ALT) ≤ 2.5 times ULN

   - Shortening fraction of ≥ 27% by echocardiogram OR ejection fraction of ≥ 50% by
   radionuclide angiogram

   - Corrected QT interval < 450 msec (males) or < 470 msec (females)

   - Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 times ULN

   - Partial thromboplastin time (PTT) ≤ 1.5 times ULN

   - Patients must not have a history of cardiac disease including, but not limited to:

      - Uncontrolled hypertension within 12 months prior to enrollment; uncontrolled
      hypertension is defined as follows:

         - Patients aged ≤ 17 years: greater than 95th percentile systolic and
         diastolic blood pressure based on age and height which is not controlled by
         one anti-hypertensive medication

         - Patients aged > 17 years: systolic blood pressure ≥ 140 mm Hg and/or
         diastolic blood pressure ≥ 90 mm Hg which is not controlled by one
         anti-hypertensive medication

      - Ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade

      - Unstable angina, symptomatic congestive heart failure, or myocardial infarction

   - Patients with a seizure disorder may be enrolled if on non-enzyme-inducing
   anticonvulsants and well controlled

      - Commonly used non-enzyme-inducing anticonvulsants include: gabapentin,
      lamotrigine, levetiracetam, tiagabine, topiramate, valproic acid, and zonisamide

   - Patients must not have had a cerebrovascular accident or transient is chemic attack
   within 12 months prior to enrollment

   - Patients must not have had a pulmonary embolism or other significant thromboembolic
   event within 12 months prior to enrollment

   - Patients must not have had grade ≥ 3 hemorrhage within 4 weeks prior to enrollment

   - Patients must not have had any of the following diagnoses within 6 months prior to
   enrollment: peptic ulcer disease, inflammatory bowel disease, or diverticulitis

   - Patients with a diagnosis of abdomen fistula, gastrointestinal (GI) perforation, or
   intra-abdominal abscess within 6 months prior to enrollment are not eligible

   - Patients who have an uncontrolled infection are not eligible

   - Patients with hypothyroidism that has not been well-controlled by medications for at
   least 2 weeks prior to study entry are not eligible

   - Patients who have a personal history of genetic and/or congenital cardiac
   abnormalities are not eligible

   - Patients who have a history of allergic reactions to compounds of similar chemical or
   biological composition to sunitinib are not eligible

   - Patients who have any other condition that could result in an inability to swallow
   capsules/sprinkles or absorb oral sunitinib administered through a gastric tube are
   not eligible

   - Patients with body surface area < 0.55 m^2 or > 2.18 m^2 are not eligible

   - Female patients who are pregnant are not eligible

   - Lactating females are not eligible unless they have agreed not to breastfeed their
   infants

   - Female patients of childbearing potential are not eligible unless a negative pregnancy
   test result has been obtained within the past 4 weeks

   - Sexually active patients of reproductive potential are not eligible unless they have
   agreed to use an effective contraceptive method for the duration of their study
   participation

   - No concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel,
   warfarin, heparin, low molecular weight heparin, dipyridamole, or aspirin therapy > 81
   mg/day

   - Patients must have fully recovered from the acute toxic effects of all prior
   chemotherapy, immunotherapy, or radiotherapy (RT) prior to entering this study

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

   - At least 7 days since the completion of therapy with a biologic agent; for 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 must have elapsed since prior therapy that included a monoclonal
   antibody

   - At least 24 weeks must have elapsed if prior full-field RT

      - ≥ 2 weeks must have elapsed if prior local palliative RT (small port) or
      limited-field RT

      - ≥ 3 months must have elapsed since prior stem cell transplant (SCT) or rescue
      with total-body irradiation (TBI)

         - No evidence of active graft-vs-host disease

   - Patients who are receiving dexamethasone must be on a stable or decreasing dose for at
   least 7 days prior to enrollment

   - Patients must not have received potent cytochrome P450-3A4 (CY3A4) inhibitors and/or
   inducers within 7 days prior to study enrollment and potent inducers within 12 days
   prior to study enrollment and during study

   - At least 7 days must have elapsed since the completion of therapy with a hematopoietic
   growth factor

   - Patients who have previously received sunitinib or who have received other VEGF-,
   PDGFR-, or KIT-targeted therapy are not eligible

      - Patients who received bevacizumab as part of their prior therapy may enroll on
      study

   - Patients must not have received more than 2 prior chemotherapy and/or RT regimens; for
   example, 1 initial treatment course of chemotherapy and/or RT (counts as 1 treatment
   course) and at relapse may have received 1 treatment course of chemotherapy and/or RT
   (counts as 1 treatment course)

   - Patients who received prior therapy with known risk for cardiovascular complications
   (e.g., anthracycline therapy or prior RT that included the heart and/or craniospinal
   radiation) are not eligible

   - Patients receiving ongoing treatment with therapeutic doses (i.e., therapeutic INR
   levels) of coumarin derivatives or oral anti-vitamin K agents are not eligible

   - Patients receiving antiretroviral therapy for human immunodeficiency virus (HIV)
   disease are not eligible

   - Patients who are started on protocol therapy on a phase II study prior to study
   enrollment are considered ineligible

   - No other concurrent chemotherapy, investigational agents, or immunomodulating agents

   - No concurrent RT

Ages Eligible for Study

1 Year - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting