Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection (NCT02500459) | Clinical Trial Compass
TerminatedEarly Phase 1
Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection
Stopped: PI Left institution
United States9 participantsStarted 2015-07-06
Plain-language summary
Topotecan is an FDA-approved drug when given by intravenous infection. The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into the part of the brain where the tumor has spread, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into tumor-infiltrated brain. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to treatment with topotecan. This study will also look at the way topotecan is injected into tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the brain with an MRI machine. This will allow the investigators to see where in the tumor-infiltrated brain the topotecan has been injected. This study will collect medical information before, during, and after treatment in order to better understand hot to make this type of procedure accessible to patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and surgical resection of the enhancing tumor is clinically indicated.
* Karnofsky Performance Status 70-100;
* MRI demonstration of an enhancing mass of more than 1 cm\^3 and less than 100 cm\^3;
* Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent; and
* Laboratory values within the following ranges:
* Absolute neutrophil count (ANC) ≥ 1,500 / μL;
* Platelet count ≥ 100,000 / μL;
* Hemoglobin ≥ 10 g / dL;
* Estimated glomerular filtration rate (eGFR) of at least 50 mL/min
Exclusion Criteria:
* Patient is mentally or legally incapacitated at the time of the study;
* Known HIV(+) or has been diagnosed with AIDS;
* Participation in another investigational drug study in the prior 4 weeks;
* Positive pregnancy test in a female;
* Patient, in the opinion of the investigator, is likely to be poorly compliant.
* Diffuse subependymal or CSF disease;
* Tumors involving the cerebellum
* Active infection requiring treatment;
* Unexplained febrile illness;
* Radiation or chemotherapy within 4 weeks of enrollment
* Systemic diseases associated with unacceptable anesthesia or operative risk;
* Personal or family history of bleedin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Summary of number of adverse events by grade - A measure of treatment safety