Status:
COMPLETED
Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors
Lead Sponsor:
Johns Hopkins All Children's Hospital
Collaborating Sponsors:
The V Foundation
Brain Tumor Alliance
Conditions:
Central Nervous System Tumors
Eligibility:
All Genders
18-23 years
Phase:
PHASE1
Brief Summary
Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently i...
Detailed Description
Bevacizumab dosing is 10 mg/kg on day 1 and day 15 of a 28 days course given IV. Irinotecan dosing is 125 mg/m2 on day 1 and day 15 of a 28 day course given IV for the first 3 dose levels. If the MTD...
Eligibility Criteria
Inclusion
- Medulloblastomas, high-grade glioma, low-grade glioma, and ependymoma are eligible. Other central nervous system tumors may be considered for treatment at discretion of investigator. Pathology is required unless diffuse intrinsic pontine glioma or optic pathway tumor.
- The patient should have failed first line therapy and be considered refractory, relapsed, or recurrent. Exceptions are high grade gliomas including brain stem gliomas.
- Age 18 months though age 23 years are eligible for this protocol.
- The patient may have received any of the agents, but not in this combination. Patients will not be eligible if they have received the combination of bevacizumab and IV irinotecan as prior therapy. They will not be eligible if they had progressive disease on any of these agents. Investigator discretion may also be used.
- Bone marrow should be recovered from prior therapy with ANC \>1500 and platelets \>100,000.
- Serum creatinine should be less than institutional upper limit of norm.
- ALT/AST \<3 times normal and bilirubin \<1.5 times normal.
- Neurologic symptoms should be stable for 1 week with stable or decreasing doses of steroids.
- Patients should not be pregnant or breast feeding.
Exclusion
- Patients with bleeding disorders or on anticoagulants.
- Uncontrolled hypertension.
- Other risks of bleeding determined on individual basis.
- Patients receiving enzyme inducing anticonvulsants.
- Patients with significant cardiac or pulmonary dysfunction that would compromise the patient's ability to tolerate protocol therapy or would likely interfere with the study procedures or results.
- For patients receiving bevacizumab, those who have had surgical procedures should not receive bevacizumab within 28 days of a major procedure, 14 days of an intermediate procedure and 7 days of a minor procedure. Lumbar punctures or placement of PICC lines are not considered minor procedures and may occur at any time prior to or during therapy.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00876993
Start Date
September 1 2008
End Date
September 1 2015
Last Update
July 3 2023
Active Locations (1)
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1
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701