Radiation Therapy for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioblastoma+1 MoreRadiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, nedisertib, to see if it can help shrink tumors when used with radiation therapy in patients with a certain type of brain cancer.

Eligible Conditions
  • Glioblastoma
  • Gliosarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 3 years

Day 10
Ability of nedisertib (M3814) to cross the blood brain barrier (Stage II)
Year 3
Median progression-free survival (Stage I)
Median progression-free survival (Stage II)
Up to 3 years
Alterations in tumor immune microenvironment
Median overall survival (Stage I)
Median overall survival (Stage II)
Overall response rate (Stage I)
Overall response rate (Stage II)
Pharmacodynamic properties of M3814
Week 10
Dose-limiting toxicities (DLT) (Stage I)
Maximum tolerated dose (MTD) (Stage I)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Stage II (nedisertib, radiation, temozolomide, surgery)
1 of 2
Stage I (nedisertib, radiation therapy, temozolomide)
1 of 2

Experimental Treatment

29 Total Participants · 2 Treatment Groups

Primary Treatment: Radiation Therapy · No Placebo Group · Phase 1

Stage II (nedisertib, radiation, temozolomide, surgery)Experimental Group · 4 Interventions: Radiation Therapy, Resection, Temozolomide, Nedisertib · Intervention Types: Radiation, Procedure, Drug, Drug
Stage I (nedisertib, radiation therapy, temozolomide)Experimental Group · 3 Interventions: Radiation Therapy, Temozolomide, Nedisertib · Intervention Types: Radiation, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2005
Completed Phase 3
~7010
Resection
2021
Completed Phase 2
~400
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,098 Previous Clinical Trials
41,145,748 Total Patients Enrolled
303 Trials studying Glioblastoma
22,486 Patients Enrolled for Glioblastoma
M.D. Anderson Cancer CenterLead Sponsor
2,810 Previous Clinical Trials
1,790,542 Total Patients Enrolled
41 Trials studying Glioblastoma
1,925 Patients Enrolled for Glioblastoma
Nazanin MajdPrincipal InvestigatorM.D. Anderson Cancer Center
Nazanin Majd, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients who have had brain surgery or a biopsy and have not received any further treatments are eligible to participate in this study.
at diagnosis The person has a Karnofsky performance status of >= 60 or Eastern Cooperative Oncology Group of <= 2 at diagnosis.
People must start treatment within 8 weeks of having a brain surgical procedure
ANC of at least 1,500 per microliter within 14 days of the start of the study.
The subject must have a platelet count of at least 100,000 cells/microliter within 14 days prior to the first day of the study.
WHO grade IV glioma tumors, which are also called glioblastomas, are very aggressive and difficult to treat
is sufficient to support a diagnosis of unmethylated GBM Any documentation of MGMT unmethylated GBM from a Clinical Laboratory Improvement Amendment (CLIA) certified laboratory can be used to support a diagnosis of unmethylated GBM.
A baseline MRI of the brain was obtained less than 2 weeks before the start of the study for participants who were currently taking a stable or tapering dose of steroids no more than 4 mg a day of dexamethasone (or equivalent dose of other steroids) for at least 3 days.