INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

Patrick Wen, MD

Summary

This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : * Abemaciclib (arm is currently closed to accrual) * Temozolomide (temodar) * Neratinib (arm is currently closed to accrual) * CC115 (arm is currently closed to accrual) * QBS10072S

Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the study drug works in treating a specific disease. "Investigational" means that the drug is being studied. In this research study, the investigators are looking to compare the effects, good and bad, of the standard of care with the three investigational agent sub-studies Abemaciclib, Neratinib, CC115, QBS10072S to help people with Glioblastoma including the specific molecular changes in the genes and proteins. The FDA has approved Temozolo…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participants must have histologically confirmed intracranial glioblastoma or gliosarcoma following maximum surgical resection. Tumors primarily localized in the infratentorial compartment will be excluded. * Participants may have had prior surgery for glioblastoma or gliosarcoma but no systemic or radiation therapy. * Age ≥ 18 years. * Karnofsky performance status ≥60 * Participants must have normal organ and marrow function as defined below: * Leukocytes ≥3,000/mL * Absolute neutrophil count ≥1,500/mL * Platelets ≥100,000/mL * Hemoglobin ≥ 9g/dl * Total bilir…

Interventions

Drug
Temozolomide
Temzolomide capsules
Drug
Neratinib
Neratinib tablets
Drug
QBS10072S
QBS10072S administered intravenously
Drug
Abemaciclib
Abemaciclib tablets
Drug
CC-115
CC-115 tablets

Locations (12)

University of Alabama at Birmingham
Birmingham, Alabama
Massachusetts General Hospital
Boston, Massachusetts
iarrillaga@mgh.harvard.edu 617-724-8770
Dana Farber Cancer Institute
Boston, Massachusetts
patrick_wen@dfci.harvard.edu 617-632-2166
Mayo Clinic
Rochester, Minnesota
Columbia University Medical Center
New York, New York
Memorial Sloan Kettering Cancer Center
New York, New York
kaleyt@mskcc.org 212-639-5122