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New treatment option for Brain Tumor, Recurrent
Official title Chronic CED of TPT for Recurrent Malignant Glioma
ClinicalTrials.gov ID: NCT06666712
What this study is testing
What is Topotecan?
Topotecan is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for brain tumor, recurrent.
Also referred to as TPT, Hycamtin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary goal of this study is to establish the safety of chronic Convection Enhanced Delivery (CED) of the chemotherapeutic drug Topotecan for patients with recurrent malignant glioma that harbors the Isocitrate Dehydrogenase mutation (IDH-mut). The secondary goal of the study is to study drug distribution and assess the tumor response to prolonged continuous CED of Topotecan.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have recurrent malignant glioma with a history of WHO grade 3-4 IDH-mutant status and evidence of radiographic progression and...
- Patients with recurrent malignant glioma, IDH-mutant, who have failed standard of care treatment are eligible.
- An MRI scan must be obtained within 30 days of enrollment and must demonstrate an enhancing mass without significant mass effect. Tumors must be less...
- Karnofsky performance score must be greater than or equal to 70.
- Men and women of childbearing potential must practice birth control. Women of childbearing potential must have a urine pregnancy test within 7 days...
You likely can't join if
- Patients with diffuse subependymal or 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...
- Patients with systemic diseases which may be associated with unacceptable anesthetic/operative risk.
- Patients who have previously received systemic topotecan for their tumor.
See the full eligibility criteria
- Patients must have recurrent malignant glioma with a history of WHO grade 3-4 IDH-mutant status and evidence of radiographic progression and suspicion of histopathological recurrence. Stereotactic biopsies will be...
- Patients with recurrent malignant glioma, IDH-mutant, who have failed standard of care treatment are eligible.
- An MRI 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 as assessed by the principal investigator...
- Karnofsky performance score must be greater than or equal to 70.
- Men and women of childbearing potential must practice birth control. Women of childbearing potential must have a urine pregnancy test within 7 days of study entry. In accordance with topotecan administration guidelines...
- Patients or appropriate legally authorized representatives must possess the ability to give Informed Consent.
- Patients must be willing to and medically capable of undergoing the surgical operation.
- Patients must be at least 18 years old.
- Patients must not have known abnormal organ and marrow function as defined below 14 days or fewer from registration:
- Leukocytes: ≥3,000/mcL
- Absolute neutrophil count : ≥1,500/mcL
- Platelets: ≥100,000/mcL
- Total bilirubin: within normal institutional limits
- AST(SGOT)/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.
- Patients with diffuse subependymal or 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...
- 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 MRI or PET scans.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan, other topoisomerase inhibitors or gadolinium compounds.
- Patients who are currently receiving treatment with agents that are metabolized solely through cytochrome P450 (CYP) 3A4/5 (CYP3A4/5) and have a narrow therapeutic index or are strong CYP2C8 inhibitors. Patients who are...
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing active infection, systemic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social...
- Women of childbearing potential who fail to demonstrate a negative pregnancy test 7 or fewer days from registration.
- Women who are breast-feeding.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.