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Cancer Vaccine

MT-201-GBM monocyte vaccine for Glioblastoma (DEMAND Trial)

Phase 1

Waitlist Available

Led By Annick S Desjardins, MD, FRCPC

Research Sponsored by Michael Gunn

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 2 years

Awards & highlights

DEMAND Trial Summary

This trial is testing a new treatment for brain tumors. The goal is to find the highest dose of the treatment that patients can tolerate.

Eligible Conditions

Glioblastoma
Malignant Glioma

DEMAND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Maximum Tolerated Dose (MTD) of MT-201-GBM

pp65 T-cell Immune Response After 2 Weeks Post Infusion Three Compared to Baseline

Secondary outcome measures

Median Overall Survival (OS)

Median Progression Free Survival (PFS)

Percentage of patients with a dose-limiting toxicity (DLT) during DLT observation period within each dose level

+1 more

DEMAND Trial Design

1Treatment groups

Experimental Treatment

Group I: MT-201-GBM monocyte vaccineExperimental Treatment1 Intervention

pp65 monocyte vaccines (MT-201-GBM) - cohorts of patients will receive increasing doses (dose escalation) of MT-201-GBM followed by a dose expansion cohort at the maximum tolerated dose. Patients will receive a total of 3 intravenous vaccines every 4 weeks after completing standard radiation therapy (XRT) and temozolomide (TMZ) and a single course of dose-intensified TMZ.

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Who is running the clinical trial?

Michael GunnLead Sponsor

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,881 Total Patients Enrolled

322 Trials studying Glioblastoma

23,115 Patients Enrolled for Glioblastoma

Annick S Desjardins, MD, FRCPCPrincipal InvestigatorDuke University

Frequently Asked Questions

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

To what degree is MT-201-GBM monocyte vaccine potentially hazardous to patients?

"As this is an early-phase clinical trial, with limited data to support its efficacy and safety, the MT-201-GBM monocyte vaccine was assigned a rating of 1."

Answered by AI

Are recruitment opportunities currently available for this trial?

"This clinical trial is no longer recruiting patients as of the 9th September, 2022. It was first posted on October 1st and has now been surpassed by 707 other studies related to glioblastoma and one study for MT-201-GBM monocyte vaccine with open recruitment."

Answered by AI

How many participants are being accepted in this medical research?

"Unfortunately, this trial has already ceased patient recruitment. It was first posted on October 1st 2022 and last updated on September 7th 2022. Nevertheless, there are 707 clinical trials currently enrolling patients with glioblastoma and one study utilising the MT-201-GBM monocyte vaccine that is still in search of participants."

Answered by AI

What are the anticipated outcomes of this research endeavor?

"The primary evaluation criteria for this two-week clinical trial is the Maximum Tolerable Dose (MTD) of MT-201-GBM. Supplementary metrics include Median Overall Survival (OS), Percentage of patients with a dose-limiting toxicity during DLT observation period within each dosage level, and Median Progression Free Survival (PFS)."

Answered by AI

What previous research has been done with the MT-201-GBM monocyte vaccine?

"Currently, one clinical trial is in progress examining the effects of MT-201-GBM monocyte vaccine and none are at stage 3. Durham, NC houses many of these studies while 1 other research centre across the nation is investigating this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Monocyte Antigen Carrier Cells for Newly Diagnosed GBM

Michael Gunn 2023. "Monocyte Antigen Carrier Cells for Newly Diagnosed GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04741984.