Status:
COMPLETED
Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors
Lead Sponsor:
Jeffrey N. Bruce
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Neoplasms, Primary Malignant
Eligibility:
All Genders
1+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. This drug...
Detailed Description
Clinical efficacy with chemotherapy has been discouraging for malignant brain tumors, mostly because of side effects and delivery limitations. Because they are locally invasive and rarely metastasize,...
Eligibility Criteria
Inclusion
- Patients with primary malignant brain tumor, or a newly diagnosed or recurrent malignant tumor of the brainstem. Patients with tumors of the brain must have been previously treated with external beam radiation. Patients with brainstem gliomas may or may not have been previously treated.
- Patients with a tumor that is stereotactically accessible (MR scan must be obtained within 30 days of enrollment and must demonstrate an enhancing mass without significant mass effect. Tumors must be less than 100 cc in total volume).
- Patients who demonstrate evidence of increasing contrast enhancement on MR or CT imaging while on stable or increasing dose of steroid.
- Patients with a Karnofsky Performance Score of greater than or equal to 60.
- Men and women of child-bearing potential must practice birth control. Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days of study entry.
- Patients must possess the ability to give Informed Consent. Parent or guardian may give informed consent for minors.
- Patients must be willing to and medically capable of undergoing the surgical operation.
- Patients may not be receiving other investigational agents for the treatment of malignant astrocytoma.
- There is no upper age limit. Patients at extreme upper end of the age spectrum will not be automatically excluded, but will be carefully scrutinized to determine their suitability for this procedure.
- Patients must be at least 1 year old to participate in the study.
Exclusion
- Patients with diffuse subependymal or cerebrospinal fluid (CSF) disease.
- Patients with tumors involving the cerebellum, or both hemispheres.
- Patients with an active infection requiring treatment or having an unexplained febrile illness.
- Patients who are known HIV positive or who are known positive for Hepatitis B or C virus
- Patients who have received any form of radiation or chemotherapy within 4 weeks of protocol enrollment.
- Patients with systemic diseases which may be associated with unacceptable anesthetic/operative risk.
- Patients who have previously received systemic topotecan for their tumor
- Patients less than 1 year of age
- Patients who are not able to receive an MRI scan
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00308165
Start Date
March 1 2004
End Date
January 1 2016
Last Update
June 27 2025
Active Locations (1)
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1
Columbia University Medical Center Neurological Institute
New York, New York, United States, 10032