INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
Overview
- Phase
- Phase 2
- Intervention
- Temozolomide
- Conditions
- Glioblastoma
- Sponsor
- Patrick Wen, MD
- Enrollment
- 460
- Locations
- 12
- Primary Endpoint
- Overall Survival in Experimental Arms Compared with Standard Therapy
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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
Detailed 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 Temozolomide (temodar) as a treatment for this disease, however the FDA has not approved Abemaciclib, CC115, Neratinib, QBS10072S for any diseases.
Investigators
Patrick Wen, MD
Director, Center for Neuro-Oncology
Dana-Farber Cancer Institute
Eligibility 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 bilirubin within normal institutional limits (except for participant's with Gilbert's disease)
Exclusion Criteria
- •Participants will not be eligible if the original diagnosis was a lower grade glioma and a subsequent histologic diagnosis revealed glioblastoma.
- •Planned major surgery.
- •Participants who are receiving any other investigational agents.
- •Participants who have had any prior cranial radiotherapy.
- •Planned use of Optune™.
- •History of a different malignancy, unless (a) have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, and/or (b) malignancy was cervical cancer in situ, superficial bladder cancer or basal cell or squamous cell carcinoma of the skin, and malignancy has been treated. Patients who meet the above listed criteria and are only on preventative treatment will be deemed eligible.
- •History of intratumoral or peritumoral hemorrhage if deemed significant by the treating physician.
- •Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of ≥2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia.
- •Known history of congenital QT prolongation or Torsade de pointes (TdP).
Arms & Interventions
Temozolomide
* Daily Radiation for a maximum of 49 days. * Temozolomide will be administered orally on a daily dosing schedule * Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy * Temozolomide will also be administered post radiation for up to 6 cycles (5 days/cycle)
Intervention: Temozolomide
Neratinib with Temozolomide
* Daily Radiation for a maximum of 49 days. * Temozolomide will be administered orally on a daily dosing schedule * Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy * Neratinib will be taken post radiation at a daily oral pre-determine dose
Intervention: Temozolomide
Neratinib with Temozolomide
* Daily Radiation for a maximum of 49 days. * Temozolomide will be administered orally on a daily dosing schedule * Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy * Neratinib will be taken post radiation at a daily oral pre-determine dose
Intervention: Neratinib
QBS10072S
Daily Radiation for a maximum of 49 days. QBS10072S will be administered on Day 1 of Radiation Treatment QBS10072S will be administered post- radiation for up to 6 cycles
Intervention: QBS10072S
Abemaciclib with Temozolomide
* Daily Radiation for a maximum of 49 days. * Temozolomide will be administered orally on a daily dosing schedule during radiation * Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy * Abemaciclib will be taken post radiation at a twice daily oral pre-determined dose
Intervention: Temozolomide
Abemaciclib with Temozolomide
* Daily Radiation for a maximum of 49 days. * Temozolomide will be administered orally on a daily dosing schedule during radiation * Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy * Abemaciclib will be taken post radiation at a twice daily oral pre-determined dose
Intervention: Abemaciclib
CC-115
* Twice daily oral dosing of CC-115 * Daily Radiation for a maximum of 49 days * CC115 will also be taken twice daily post radiation
Intervention: CC-115
Outcomes
Primary Outcomes
Overall Survival in Experimental Arms Compared with Standard Therapy
Time Frame: 2 years
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events(2 years)
- Overall Survival Among Experimental Arms And Biomarker Groups(2 years)
- Association Between Progression Free Survival and Overall Survival Effects Of Experimental Agents(2 years)
- Progression Free Survival Among Experimental Arms And Biomarker Groups(2 years)