View Clinical Trial (Medical Research Study)
A Phase I Study Of Irinotecan and Bevacizumab With Temozolomide in Children With Recurrent/Refractory Central Nervous System Tumors
| City: |
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St. Petersburg |
| State: |
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Florida |
| Zip Code: |
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33701 |
| Conditions: |
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Central Nervous System Tumors |
| Purpose: |
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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 in progress within the major consortiums with this combination of drugs.
Brain tumors are the second most common cause of cancer in pediatrics and the leading cause
of cancer death in children. For children with High Grade Gliomas or with
relapsed/refractory brain tumors, new agents in new combinations are needed. Historical
data shows that newly diagnosed high grade gliomas 5 year progression free survival is
28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent
medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide
an objective observation of toxicity and establish a maximum tolerated dose of this
combination. In addition, this study will observe the response of children with relapsed or
refractory central nervous system tumors.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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.
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| NCT ID: |
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NCT00876993 |
| Primary Contact: |
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Stacie Stapleton, MD
Phone: 727-767-4176
Email: Stacie.Stapleton@allkids.org
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| Backup Contact: |
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Email: Frances.Hamblin@allkids.org
Frances Hamblin, RN
Phone: 727-767-2423
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| Location Contact: |
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St. Petersburg, Florida 33701
United States
Stacie Stapleton, MD
Phone: 727-767-4176
Email: Stacie.Stapleton@allkids.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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