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Immunostimulator

Temozolomide for Malignant Glioma (GMCI Trial)

Phase 1
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 up to 2 years
Awards & highlights

GMCI Trial Summary

This trial is testing the safety of combining GMCI, an immunostimulator, plus nivolumab, an immune checkpoint inhibitor, with standard of care radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas.

Eligible Conditions
  • Malignant Glioma

GMCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Immune characterization as determined by Cytokines
Immune characterization as determined by Extracellular vesicles (EVs) proteins
Immune profiling - Tumor Tissue
+4 more

GMCI Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: MGMT Methylated & undetermined PatientsExperimental Treatment6 Interventions
After confirmation of high grade glioma, AdV-tk injection into wall of resection cavity. Valacyclovir starting 1-3 days post-surgery for 14 days. Radiation begins approximately day 8. Temozolomide started after complete valacyclovir and continue during radiation then 5 week break and then begin adjuvant temozolomide dosing. Nivolumab every 2 weeks x 26 doses up to 52 weeks. MRI every 8 weeks until progression.
Group II: Cohort 1: MGMT Unmethylated PatientsExperimental Treatment6 Interventions
After confirmation of high grade glioma, AdV-tk injection into wall of resection cavity. Valacyclovir starting 1-3 days post-surgery for 14 days. Radiation begins approximately day 8 and continues for 6 weeks. Temozolomide started after complete valacyclovir and stop when MGMT unmethylated result obtained. Nivolumab every 2 weeks x 26 doses up to 52 weeks. MRI every 8 weeks until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Valacyclovir
2008
Completed Phase 4
~2520
Temozolomide
2010
Completed Phase 3
~1930
Radiation
2003
Completed Phase 3
~1020
AdV-tk
2008
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Candel Therapeutics, Inc.Industry Sponsor
11 Previous Clinical Trials
1,237 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,478 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,864 Total Patients Enrolled

Media Library

GMCI (Immunostimulator) Clinical Trial Eligibility Overview. Trial Name: NCT03576612 — Phase 1
Malignant Glioma Research Study Groups: Cohort 1: MGMT Unmethylated Patients, Cohort 2: MGMT Methylated & undetermined Patients
Malignant Glioma Clinical Trial 2023: GMCI Highlights & Side Effects. Trial Name: NCT03576612 — Phase 1
GMCI (Immunostimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03576612 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How prevalent is this examination in North American medical facilities?

"This clinical trial is running at multiple sites, including the Hillman Cancer Center of University of Pittsburgh's Cancer Institute in Pittsburgh, Pennsylvania; Wake Forest University Comprehensive Cancer Center in Winston-Salem, North carolina; and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland."

Answered by AI

To what extent is the selection process for this clinical trial open?

"At this moment, patient recruitment is not being conducted for the trial. It was first announced on February 27th 2018 and last updated on August 5th 2022. If you seek other trials, there are currently 356 studies recruiting glioma patients and 924 Temozolomide related clinical trials enrolling participants."

Answered by AI

Are there extant investigations on Temozolomide?

"Temozolomide was initially explored in 2002 at the renowned Memorial Sloan Kettering Cancer Center. To date, 1216 completed trials have been conducted, while a total of 924 are currently underway with many of these studies located in Pittsburgh, Pennsylvania."

Answered by AI

In what situations is Temozolomide typically recommended as a treatment?

"Temozolomide is frequently used to treat malignant neoplasms and can be a viable option for patients with unresectable melanomas, squamous cell carcinomas, or those at risk of recurrent cancer."

Answered by AI

Are there any ongoing opportunities to participate in this trial?

"As per information found on clinicaltrials.gov, this particular medical trial is no longer in search of candidates - the initial post date being February 27th 2018 and last update August 5th 2022. Despite that, 1280 other trials are currently enrolling participants."

Answered by AI

Is this an unprecedented or groundbreaking exploration?

"Presently, there are 924 ongoing clinical trials for Temozolomide in 2456 cities and 51 nations. The inaugural study of this drug was initiated back in 2002 by Schering-Plough; it included 60 patients and concluded the Phase 2 medication approval process. Since then, 1216 experiments have been finished."

Answered by AI

Has the FDA sanctioned Temozolomide for therapeutic use?

"Limited evidence exists for Temozolomide's safety and efficacy, prompting us to assign a rating of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas
2018. "GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03576612.
~5 spots leftby Apr 2025
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