Status:
COMPLETED
Bevacizumab and Irinotecan in Treating Young Patients With Recurrent, Progressive, or Refractory Glioma, Medulloblastoma, Ependymoma, or Low Grade Glioma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Childhood Cerebral Anaplastic Astrocytoma
Childhood Oligodendroglioma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving bevacizumab together with irinotecan works in treating young patients with recurrent, progressive, or refractory glioma, medulloblastoma, ependymoma, or...
Detailed Description
PRIMARY OBJECTIVES: I. Estimate the rates of objective response observed prior to disease progression during the first four courses of treatment with bevacizumab and irinotecan hydrochloride in pedia...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed high-grade glioma (WHO grade III or IV) at any site within the brain, including the following:
- Anaplastic astrocytoma
- Glioblastoma multiforme (including giant cell and gliosarcoma subtypes)
- Anaplastic oligodendroglioma
- Anaplastic ganglioglioma
- Anaplastic oligoastrocytoma
- Diffuse brain stem glioma
- Histologic confirmation not required
- Histologically confirmed medulloblastoma
- Histologically confirmed ependymoma
- Primary spinal cord malignant glioma with measurable metastatic disease within the brain
- Histologic confirmation required
- Neuraxis dissemination allowed provided there is bidimensionally measurable disease within the brain and spinal cord
- Low grade glioma at any site within the brain with or without spinal cord disease
- Recurrent, progressive, or refractory disease (must have received prior chemoradiotherapy)
- No more than 2 prior chemotherapy regimens following relapse
- Bidimensionally measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 2 planes
- If there is spinal cord disease as well, response assessment will be based only upon the measurable tumor in the brain
- No diffuse gliomatosis cerebri with \< 1 discrete, measurable lesion
- No evidence of new symptomatic CNS hemorrhage (\> grade 2) within the past 2 weeks
- No central non-cerebellar PNET's (e.g., cerebral PNET or pineoblastoma)
- No spinal cord tumors only
- Karnofsky performance status (PS) 50-100% (\> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age)
- Absolute neutrophil count ≥ 1,500/mm³ (unsupported)
- Platelet count ≥ 100,000/mm³ (unsupported)
- Hemoglobin \> 8 g/dL (support allowed)
- Creatinine normal
- BUN \< 25 mg/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 3 times ULN
- Neurological deficits must be stable for ≥ 1 week prior to study entry
- No active renal, cardiac (congestive cardiac failure, myocarditis), or pulmonary disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
- No clinically significant unrelated systemic illness that would preclude study treatment, including any of the following:
- Serious infections
- Significant cardiac, pulmonary, hepatic, or other organ dysfunction
- No uncontrolled systemic hypertension, defined as systolic blood pressure (BP) and/or diastolic BP \> 95th percentile for age
- No stroke, myocardial infarction, or unstable angina within the past 6 months
- No clinically significant peripheral vascular disease
- No significant traumatic injury within the past 6 weeks
- No evidence of bleeding diathesis, coagulopathy, or PT INR \> 1.5
- Urine protein/creatinine ratio ≤ 1.0
- No abdominal fistula or gastrointestinal perforation within the past 6 months
- No serious nonhealing wound, ulcer, or bone fracture
- At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas)
- At least 7 days since prior investigational or biologic agents (3 weeks if patient experienced ≥ grade 2 myelosuppression or if agent has a prolonged half-life)
- More than 7 days since prior minor surgery
- More than 12 weeks since prior craniospinal or focal irradiation to primary tumor or other sites
- At least 4 weeks since prior major surgery and recovered
- At least 3 months since prior autologous bone marrow or stem cell transplantation
- At least 2 weeks since prior colony-forming growth factors (i.e., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], epoetin alfa)
- No prior bevacizumab or irinotecan hydrochloride
- No anticipated surgery during treatment
- No concurrent prophylactic G-CSF, GM-CSF, or epoetin alfa
- Concurrent dexamethasone allowed provided the dose is stable or decreasing over the past week
- No other concurrent anticancer or investigational drugs
- No concurrent medications that may interfere with study (e.g., immunosuppressive agents other than corticosteroids)
- No concurrent therapeutic anticoagulation
- No concurrent nonsteroidal anti-inflammatory drugs, clopidogrel bisulfate, dipyridamole, or acetylsalicylic acid (aspirin) \> 81 mg/day
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00381797
Start Date
August 1 2006
End Date
October 1 2015
Last Update
November 28 2017
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115