Status:
COMPLETED
Super-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab)
Lead Sponsor:
Northwell Health
Conditions:
Glioblastoma Multiforme
Anaplastic Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits th...
Detailed Description
The current standard of care for recurring GBM is for patients to receive Bevacizumab (Avastin) intravenously (IV) at 10mg/kg with CPT-11 (Irinotecan) every two weeks until their tumor grows more than...
Eligibility Criteria
Inclusion
- INCLUSION
- Male or female patients of greater or equal18 years of age.
- Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA)
- Patients with a histologically confirmed low-grade brain tumor who relapse with an enhancing tumor on MRI can be evaluated for toxicity only.
- Patients must have at least one confirmed and evaluable tumor site.
- \*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within three weeks of treatment on this research study.
- Patients must have a Karnofsky performance status greater or equal to 60% (or the equivalent ECOG level of 0-2) (see Appendix A; Performance Status Evaluation) and an expected survival of greater or equal to three months.
- Patients must be able to understand informed consent. Informed consent must be obtained at the time of patient screening.
- Because of known concerns with Avastin and wound healing, all craniotomy patients are eligible for the treatment if they have had a craniotomy \> two weeks prior to IA therapy. Craniotomy after SIACI bevacizumab therapy should wait 4 weeks.
- Pre-enrollment coagulation parameters (PT and PTT) must be less than or equal to1.5X the IUNL.
- Patients must have adequate hematologic reserve with WBC greater than or equal to 2800/mm3, absolute neutrophils greater than or equal to1500/mm3 and platelets greater than or equal to 100,000/ mm3.
- Pre-enrollment chemistry parameters must show: bilirubin\<1.5X the institutional upper limit of normal (IUNL); AST or ALT\<2.5X IUNL and creatinine\<1.5X IUNL.
- No external beam radiation for four weeks prior to treatment under this research protocol.
- No chemotherapy for three weeks prior to treatment under this research protocol.
- EXCLUSION:
- Patients previously treated with more than 6 cycles (28 days each) of Bevacizumab at 10/mg/kg.
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men who decline to use effective contraception during and for a period of three months after the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00968240
Start Date
July 1 2009
End Date
January 1 2014
Last Update
April 22 2015
Active Locations (1)
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1
Lenox Hill Brain Tumor Center
New York, New York, United States, 10075