CompletedPhase 2

Protein Phosphatase 2A Inhibitor, in Recurrent Glioblastoma

United States7 participantsStarted 2019-01-09

Plain-language summary

Background: The brain is separated from the rest of the blood stream by the blood-brain barrier. This is like a filter that protects the brain. But is also a challenge when medicines need to get into the brain. Researchers want to give the new drug LB100 to people before brain tumor surgery. They will measure how much LB100 is in the blood and how much gets into the brain. This may help with the use of LB100 to treat brain tumors in the future. Objective: To see if LB100 can pass into the brain. Eligibility: People at least 18 years old with a brain tumor that requires surgery. Design: Participants will be screened with: Physical exam Medical history Blood tests Neurosurgery evaluation Scans Heart tests Tumor sample. This can be from a previous procedure. Participants will have their brain surgery at the Clinical Center. Participants will get a dose of the study drug through a plastic tube in a vein for 2 hours during surgery. Participants will have blood taken 7 times in the 8 hours after getting the study drug. Tumor samples will be taken during surgery. Participants will have a heart test after getting the study drug. Sticky pads on the skin will measure electrical activity of the heart. Two-three weeks after leaving the hospital, participants will have a follow-up visit. They will have a physical exam and blood tests. One month after surgery, they will be contacted in person or by phone to see how they are doing.

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: * Patients must have histologically confirmed glioblastoma/gliosarcoma, grades II-III astrocytoma and oligodendroglioma. * Patients must have recurrent disease for which there is a clinical indication for resection. * Age greater than or equal to18 years. * Karnofsky greater than or equal to 60%. * Patients must have adequate bone marrow function (white blood count (WBC) greater than or equal to 3,000/uL absolute neutrophil count (ANC) greater than or equal to 1,500/mm\^3, platelet count of greater than or equal to 100,000/mm\^3, and hemoglobin greater than or equal to 10 gm/dL), adequate liver function (SGOT and bilirubin \< 2 times upper limit of normal (ULN). These tests must be performed within 28 days prior to receiving drug. Eligibility level for hemoglobin may be reached by transfusion. * Patients must have a serum creatinine of \<=1.7 mg/dL. If the serum creatinine is greater than 1.7 mg/dl, a 24-hour urine creatinine clearance will be obtained and if the result of this study is within normal limits\*, the patient would be eligible to enroll onto study. This test must be performed within 28 days prior to registrationreceiving drug. (\*Normal Creatinine Clearance Range: Male: 90 - 130 ml/min; Female: 80 - 125 ml/min) * Patients must be in adequate general medical health to safely tolerate a craniotomy. * At the time of registration, all subjects must be removed greater than or equal to 28 days from any investigational agents. * The effects of LB10…

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

Number of Participants With the Presence of Drug in the Tumor Tissue

Timeframe: an average of 5.5 hours after drug administration

Trial details

NCT IDNCT03027388

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2022-08-15

Results submitted2023-08-11

View on ClinicalTrials.gov More Astrocytoma, Grades II, III and IV trials