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New treatment option for Glioblastoma
Official title INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
ClinicalTrials.gov ID: NCT02977780
What this study is testing
What is Temozolomide?
Temozolomide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glioblastoma.
Also referred to as Temodar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically confirmed intracranial glioblastoma or gliosarcoma following maximum surgical resection. Tumors primarily...
- 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:
You likely can't join 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- For women of child bearing potential (women who are not free from menses for \> 2 years, post hysterectomy/oophorectomy, or surgically sterilized) a negative serum pregnancy test must be documented prior to initial...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 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...
- 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...
- 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 people 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...
- 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.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the experimental agents or other agents used in study.
- Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participant must be off...
- Participants taking a drug known to be strong inhibitors or inducers of isoenzyme CYP3A. Participant must be off CYP3A inhibitors and inducers for at least 7 days prior to planned start of study treatment. NOTE...
- Current use of herbal preparations/medications, including but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng. Participants should...
- Current use of warfarin sodium or any other coumadin-derivative anticoagulant. Participant must be off Coumadin-derivative anticoagulants for at least 7 days prior to planned start of study treatment. Low molecular...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; New York, New York, United States; Cleveland, Ohio, United States; Pittsburgh, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.