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Chemotherapy delivered straight to the brain: a new hope for recurrent tumors?
NCT ID NCT00308165
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a method called convection-enhanced delivery to pump the chemotherapy drug topotecan directly into brain tumors in 16 patients with recurrent malignant brain tumors. The goal was to see if this approach is safe and to find the best dose, while also monitoring tumor progression and quality of life. Because it is a phase 1 trial, the main focus is on safety, not yet on whether it works as a treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Topotecan (chemotherapy drug)
- What this could lead to
- If successful, this approach could offer a new way to deliver chemotherapy directly to brain tumors, potentially improving treatment effectiveness while reducing side effects.
- What could go wrong
- This is a very early phase 1 trial with only 16 participants, focused on safety and dosing. It is not designed to prove the treatment works, and the drug may still cause serious neurological side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
16 people
The number who actually took part.
- Started
-
Mar 2004
- Finished
-
Jan 2016
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 year and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Columbia University Medical Center Neurological Institute
New York, New York, 10032, United States
More trials for these conditions
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