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Alkylating agents
PCI-24781 + Temozolomide for Recurrent Brain Cancer
Phase 1
Recruiting
Led By Nicole Shonka, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial aims to find a better treatment for glioma, a type of brain cancer. It studies the effects of combining PCI-24781 and metronomic temozolomide to see if it can help those whose cancer has returned.
Who is the study for?
This trial is for adults over 19 with recurrent high-grade glioma who've had prior radiation and temozolomide treatment. They must have good liver, kidney, and bone marrow function, not be pregnant or nursing, and agree to use birth control. Excluded are those with certain heart conditions, other active cancers (except some skin/prostate), specific infections or systemic illnesses that could affect safety.Check my eligibility
What is being tested?
The study tests the combination of a drug called PCI-24781 with low-dose Temozolomide in patients whose brain cancer has returned. It aims to find the safest dose of this combo and assess its side effects in treating high-grade gliomas like astrocytoma or glioblastoma.See study design
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Specific side effects related to PCI-24781 may also occur but are being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the recommended dose of PCI-24781/Abexinostat
Evaluation of toxicities associated with PCI-24781/Abexinostat and metronomic temozolomide therapy (AEs & SAEs)
Evaluation of toxicities associated with PCI-24781/Abexinostat and metronomic temozolomide therapy (overall, graded 1-5)
Secondary outcome measures
Correlation of molecular profiles with tumor response
Descriptive examination of patient quality of life (QOL) during treatment - EORTC QLQ-BN20 Questionnaire
Descriptive examination of patient quality of life (QOL) during treatment - EORTC QLQ-C30 Questionnaire
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment2 Interventions
Patients will receive a combination of PCI-24781/Abexinostat and temozolomide. Patients will receive a loading dose of PCI-24781/Abexinostat prior to the start of Cycle 1; patients will take PCI-24781/Abexinostat by mouth twice a day starting 7 days prior to Cycle 1, Day 1 and ending 4 days prior to Cycle 1, Day 1.
Patients will continue taking PCI-24781/Abexinostat on days 1-4, 8-11, 15-18, and 22-25 of each 28 day cycle, starting with Cycle 1, Day 1. The initial dose level is 60 mg of PCI-2478/Abexinostat 1 by mouth twice daily. The dose level may be escalated based on results of interim data analysis.
Patients will additionally initiate metronomic temozolomide on Cycle 1, Day 1 at a dose of 50 mg/m2, taken by mouth twice daily. Patients will continue the PCI-24781/Abexinostat and metronomic temozolomide regimen until disease progression or intolerance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,716 Total Patients Enrolled
Xynomic Pharmaceuticals, Inc.Industry Sponsor
10 Previous Clinical Trials
1,191 Total Patients Enrolled
Nicole Shonka, MDPrincipal InvestigatorUniversity of Nebraska
5 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of previous cancer treatments.I've had radiation and temozolomide treatment for my cancer.I have recently used specific medications or therapies.I am 19 years old or older.I have a serious heart condition.I have a condition that affects how my body absorbs nutrients.I have a history of HIV, hepatitis, or an ongoing serious infection.I am currently taking valproic acid or another HDAC inhibitor.I am able to care for myself and perform daily activities.I cannot stop taking certain medications before joining the study.My liver is working well.I have been diagnosed with a high-grade brain tumor.I am currently taking certain medications for epilepsy.I am a woman who can have children and my pregnancy test is negative.My kidneys are working well.My blood tests show my bone marrow is working well.I do not have any severe illnesses that could make treatment unsafe for me.It's been over 3 months since my last chemoradiotherapy, or I have signs of my cancer getting worse.I have another active cancer besides the one being studied.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given clearance to any single arm trials?
"As Single Arm is in its earliest phase of research, this medication's safety has been rated a 1 due to the limited data available on efficacy and safety."
Answered by AI
Is the research team currently seeking new participants for this experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this exploratory medical trial is actively searching for 18 participants from one location. The study was first posted on June 26th 2023 and updated most recently on July 10th 2023."
Answered by AI
What is the approximate size of the population being treated as part of this investigation?
"Yes, according to clinicaltrials.gov this study is actively enrolling participants with the first post on June 26th 2023 and last update occurring July 10th 20203. The current goal is to secure eighteen patients from one location."
Answered by AI
What results are investigators striving to achieve with this medical experiment?
"As the primary outcome, this study aims to ascertain an optimal dosage of PCI-24781 over a 25 month period. Secondary objectives focus on estimating progression-free survival through Kaplan Meier analysis and examining patient quality of life using EORTC QLQ-BN20 scoring system as well as gauging tumor response via RANO Criteria."
Answered by AI
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