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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
Patient must have completed chemoradiation with Radiotherapy and Temozolomide of the primary tumor according to standard of care
Patients must have received no more than 3 prior therapies for Recurrent High Grade Glioma
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have finished treatment with radiation and Temozolomide for my primary tumor.
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I have had 3 or fewer treatments for my high-grade brain tumor.
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I can care for myself but may need occasional help.
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My blood and organ function tests are within the required ranges.
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I am using two birth control methods or am not having sex to avoid pregnancy during and 120 days after the study.
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My diagnosis of glioblastoma has been confirmed by a pathology report.
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My tumor is located in the upper part of my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks for 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks for 24 months for reporting.

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
336 Previous Clinical Trials
75,910 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

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT05700955 — Phase 1
Glioblastoma Research Study Groups: Pembrolizumab, temozolomide
Glioblastoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05700955 — Phase 1
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05700955 — Phase 1

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
~10 spots leftby Jan 2025