Your session is about to expire
← Back to Search
Chemoimmunotherapy for Glioblastoma
Phase 1
Recruiting
Led By Donald Miller, MD
Research Sponsored by University of Louisville
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 every 8 weeks for 24 months
Awards & highlights
Study Summary
This trial will test a new treatment for brain cancer to see if it's safe and effective.
Who is the study for?
This trial is for adults with confirmed glioblastoma, limited to the brain's upper part, who have completed standard chemoradiation. They must have adequate blood counts and organ function, no more than three prior treatments for high-grade glioma, and be able to consent. Women of childbearing age must test negative for pregnancy and use birth control; men also need contraception.Check my eligibility
What is being tested?
The study tests Pembrolizumab combined with Temozolomide's safety in treating recurrent glioblastoma. It aims to understand how this combination affects the tumor and immune system of participants.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs or skin rashes. Temozolomide can lead to nausea, fatigue, constipation, headache or affect blood cell counts increasing infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks for 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks for 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment toxicity
Secondary outcome measures
Neurologic function and quality of life
Overall Survival
Treatment Toxicity
Trial Design
2Treatment groups
Experimental Treatment
Group I: temozolomideExperimental Treatment1 Intervention
Participants will take Temozolomide pills at home at a dose determined by body weight. They will take the pills for five days every 3 weeks. It will be dispensed by the pharmacy and must be stored in a closed container at room temperature, away from heat, moisture, and direct light and kept from freezing. It will be kept out of the reach of children. Outdated medicine or medicine no longer needed will be returned to the Brown Cancer Center pharmacy for disposal.
Group II: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab will be administered at a dose of 200 mg as an IV infusion through a freely flowing IV. The diluted solution will be administered intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. Other drugs will not be co-administered through the same infusion line. Pembrolizumab doses will be repeated every three weeks.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,655 Total Patients Enrolled
1 Trials studying Glioblastoma
40 Patients Enrolled for Glioblastoma
Donald Miller, MDPrincipal InvestigatorUniversity of Louisville/James Graham Brown Cancer Ctr.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had 3 or fewer treatments for my high-grade brain tumor.I have previously received immunotherapy, like a vaccine or dendritic cell vaccine.The original tumor sample from my diagnosis is available for review.I can understand and am willing to sign the consent form.I have not had cancer (other than non-melanoma skin cancer) in the last 3 years.I have taken a pregnancy test in the last 72 hours and it was negative.I agree to use birth control during and for 4 months after the study.I am using two birth control methods or am not having sex to avoid pregnancy during and 120 days after the study.My diagnosis of glioblastoma has been confirmed by a pathology report.My tumor is located in the upper part of my brain.I can care for myself but may need occasional help.My blood and organ function tests are within the required ranges.I have finished treatment with radiation and Temozolomide for my primary tumor.
Research Study Groups:
This trial has the following groups:- Group 1: temozolomide
- Group 2: Pembrolizumab
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 sanctioned temozolomide for therapeutic use?
"The safety rating for temozolomide is 1 due to the lack of clinical data available, as this drug has only recently gone through Phase 1 trials."
Answered by AI
Is this research accepting new participants?
"As indicated by records hosted on clinicaltrials.gov, this research is actively seeking out volunteers and has been since November 1st 2022 following its most recent update from January 18th 2023."
Answered by AI
What is the cap on enrolment in this clinical investigation?
"Confirmed. Clinicaltrials.gov attests that this medical trial, which was initially advertised on November 1st 2022, is actively searching for participants. A total of 30 individuals are required to enroll from one particular clinical site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger