INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

Recruiting now · Phase 2

Conditions studied: Glioblastoma

In brief

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

Key facts

Study ID

NCT02977780

Run by

Patrick Wen, MD

People needed

460

Starts

2017-02-09

Expected to finish

2028-04-30

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal
• Creatinine ≤ institutional upper limit of normal OR
• Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
• Potassium within normal institutional range, or correctable with supplements
• Serum amylase ≤ 1.5 x institutional upper limit of normal
• Serum lipase ≤ 1.5 x institutional upper limit of normal
• INR < 2.0
• PTT ≤ institutional upper limit of normal, unless receiving therapeutic low molecular weight heparin
• Must be able to swallow pills.
• Participants must plan to begin radiation therapy 14-42 days after surgical resection.
• Immunohistochemically negative for IDH1 R132H mutation.
• Evidence that the tumor MGMT promoter is unmethylated by standard of care assays.
• Genotyping data available or in process (data must be available at time of initial registration if randomization probabilities differ across biomarker subgroups as determined by the DFCI Coordinating Center) to assign biomarker subgroups through whole exome sequencing, whole genome copy number analysis, or a combination as described in Section 9.1.
• MRI with gadolinium should be obtained within 21 days prior to beginning treatment. Patients without measurable disease are eligible. Participants must be able to undergo MRIs (CTs are not allowed for response assessment on study).
• The effects of the experimental agents used in this study on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (women who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation unless otherwise specified in sub-study that the participant is randomized to. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

You may not qualify if…

• 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).
• Complete left bundle branch or bifascicular block.
• -QTc interval > 450 ms for men or > 470 ms for women.
• Persistent or history of clinically meaningful ventricular arrhythmias or atrial fibrillation.
• Unstable pectoris or myocardial infarction ≤ 3 months prior to starting study treatment.
• Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg).
• Other clinically significant heart disease such as congestive heart failure requiring treatment.
• Uncontrolled diabetes mellitus, or subjects with either of the following:
• Fasting blood glucose (FBG defined as fasting for at least 8 hours) ≥ 200 mg/dL (7.0 mmol/L), or
• HbA1c ≥ 8%
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations.
• Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNS [qualitative] is detected).
• Known acute or chronic pancreatitis.
• Participants with active diarrhea ≥ CTCAE grade 2 despite medical management.
• Active infection requiring antibiotics.
• Pregnant or breastfeeding.

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Lifespan / Rhode Island Hospital — Providence, Rhode Island, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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