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Brain tumor chemo delivered by pump shows promise in tiny safety trial

NCT ID NCT03154996

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested whether pumping the chemotherapy drug topotecan directly into the brain is safe for people with recurrent high-grade gliomas (aggressive brain tumors). Only 5 patients took part, and the main goal was to find a safe dose. The drug was delivered continuously through a small pump implanted under the skin. While the trial is too small to say if it works, it lays groundwork for future studies on this direct-delivery approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Topotecan (a chemotherapy drug)
What this could lead to
If it works, this could point toward a new way to deliver chemotherapy directly to brain tumors, potentially improving treatment for recurrent gliomas.
What could go wrong
This is a very early, tiny trial (only 5 people) focused on safety, not effectiveness. The drug is delivered directly into the brain, which carries risks like infection or brain injury.

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

5 people

The number who actually took part.

Started

Jan 2018

Finished

Aug 2021

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

18 years and older

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have a recurrent malignant glioma (World Health Organization (WHO) grade III-IV), including recurrent glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, and anaplastic ependymoma. Stereotactic biopsies will be performed to confirm this diagnosis prior to initiating the treatment. * Patients with tumors of the brain must have been previously treated with surgical resection, external beam radiation, and temozolomide chemotherapy. * An magnetic resonance (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 32 cc in total volume. The lesion must be stereotactically accessible. * Patients must have demonstrated evidence of increasing contrast enhancement on MR or computed tomography (CT) imaging while on stable or increasing dose of steroid. * Karnofsky performance score of greater than or equal to 60. * Men and women of childbearing potential must practice birth control. Women of child bearing potential must have a urine pregnancy test within 7 days of study entry. * Patients must possess the ability to give Informed Consent. * Patients must be willing to and medically capable of undergoing the surgical operation. * 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 18 years old. * Patients must have normal organ and marrow function as defined below: * Leukocytes: ≥3,000/ cells per microliter of blood (mcL) * Absolute neutrophil count: ≥1,500/mcL * Platelets: ≥100,000/mcL * Total bilirubin: within normal institutional limits * aspartate aminotransferase (AST) (SGOT)/alanine aminotransferase (ALT) (SGPT): ≤2.5 × institutional upper limit of normal * Creatinine: within normal institutional limits OR * Creatinine clearance: ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. Exclusion Criteria: * Patients with diffuse subependymal or cerebral spinal fluid (CSF) disease. * Patients with tumors involving the cerebellum or both cerebral hemispheres. * Patients with an active infection requiring treatment or having an unexplained febrile illness. * Patients who are known HIV, Hepatitis B or Hepatitis C positive. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with topotecan. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. * Patients with systemic diseases which may be associated with unacceptable anesthetic/operative risk. * Patients who have previously received systemic topotecan for their tumor * Patients who are not able to receive an MRI scan. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan, other topoisomerase inhibitors or gadolinium compounds.

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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 Irving Medical Center

    New York, New York, 10032, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.