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Combination Chemotherapy + Radiation for Brain Tumor
Phase 2 & 3
Waitlist Available
Led By Maryam Fouladi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have newly diagnosed high-grade glioma including anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, and primary spinal cord malignant glioma
No M+ disease (evidence of neuraxis dissemination)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after enrollment
Awards & highlights
Study Summary
This trial is testing vorinostat, temozolomide, or bevacizumab to see which is more effective when given with radiation therapy to treat high-grade glioma in young patients.
Who is the study for?
This trial is for young patients with newly diagnosed high-grade glioma, including specific types like anaplastic astrocytoma and glioblastoma multiforme. Participants must have a certain level of physical function, adequate blood counts, controlled blood pressure, no evidence of widespread cancer in the nervous system or positive spinal fluid tests. Pregnant women are excluded and participants must agree to use contraception.Check my eligibility
What is being tested?
The study compares the effectiveness of vorinostat, temozolomide, and bevacizumab when combined with radiation therapy followed by additional treatments with bevacizumab and temozolomide. It aims to determine which combination works best at stopping tumor growth by killing cells or preventing them from dividing.See study design
What are the potential side effects?
Potential side effects include bleeding risks due to bevacizumab's effect on blood vessels; liver function changes; fatigue; digestive issues from chemotherapy drugs like temozolomide; and possible reactions related to vorinostat's enzyme-blocking actions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a high-grade brain or spinal cord tumor.
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My cancer has not spread to my brain or spinal cord.
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I can take care of myself but might not be able to do heavy physical work.
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I am over 16 and can do most activities without help.
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My blood pressure is 150/100 mm Hg or lower.
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My child can do most activities but may need help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free Survival
Maximum Tolerated Dose (MTD) of Vorinostat
Secondary outcome measures
Upper arm
Overall Survival
Trial Design
6Treatment groups
Experimental Treatment
Group I: Feasibility (vorinostat)Experimental Treatment3 Interventions
Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at 230 mg/m2/day. In the event of 2 or more DLTs, participants will de-escalate to vorinostat at 180 mg/m2/day. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.
Group II: Arm V (vorinostat/bevacizumab, Phase 3, Chemoradiotherapy)Experimental Treatment3 Interventions
Patients receive treatment as in phase II, arm I or phase II, arm III, whichever was established as superior in phase II. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.
Group III: Arm IV (temozolomide, Phase 3 Arm B)Experimental Treatment2 Interventions
Patients undergo RT as in the Arm II and receive temozolomide PO once daily for 42 days beginning on day 5 of RT. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.
Group IV: Arm III (Bevacizumab, Phase II Arm)Experimental Treatment2 Interventions
Patients undergo RT as in the feasibility arm and receive bevacizumab IV over 30-90 minutes on days 22 and 36. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.
Group V: Arm II (temozolomide, Phase II Arm B)Experimental Treatment2 Interventions
Patients undergo RT as in the feasibility arm and receive temozolomide PO once daily for 42 days by day 5 of RT. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.
Group VI: Arm I (vorinostat, Phase II Arm A)Experimental Treatment3 Interventions
Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the maximum-tolerated dose determined in the feasibility study. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Vorinostat
2014
Completed Phase 3
~1600
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,052 Total Patients Enrolled
Maryam FouladiPrincipal InvestigatorChildren's Oncology Group
9 Previous Clinical Trials
412 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ALT level is not more than 2.5 times the upper limit of normal.My seizures are under control with specific medication.Your diagnosis must be confirmed through tissue or cell examination.I have had a serious brain bleed after surgery in the last 2 weeks.I have a history of cancer.Your bilirubin levels are not higher than 1.5 times the upper limit of normal.My blood pressure is 150/100 mm Hg or lower.My kidney function, measured by creatinine clearance or GFR, is normal or near normal.I have been diagnosed with oligodendroglioma or oligoastrocytoma.You have taken a test that shows you are not pregnant.I am not taking HDAC inhibitors like valproic acid.I am taking anti-inflammatory medications that affect blood clotting.I have had a blood clot in my veins or lungs but don't have a known clotting disorder.I have been diagnosed with a high-grade brain or spinal cord tumor.I have a history of serious heart conditions or poorly controlled heart rhythm problems.I have a serious or non-healing wound, ulcer, or bone fracture.I have had chemotherapy, radiotherapy, immunotherapy, or a bone marrow transplant before.I will use birth control during and for 6 months after my treatment.I have had a condition where my lymphocytes multiply unusually.I have had a stroke or mini-stroke before.I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 6 months.I haven't had cancer in the last 5 years, except for skin cancer.I have a bleeding disorder.I am taking blood thinners only for existing catheters or post-surgery clot prevention.I am not currently taking any cancer treatments.I am not taking any medication that increases the activity of enzymes that control drug metabolism.My cancer has not spread to my brain or spinal cord.Your cerebrospinal fluid does not show any signs of cancer cells.It has been over a month since my last surgery.Your hemoglobin level is at least 8.0 mg/dL without needing a blood transfusion.Your blood albumin level is at least 2 grams per deciliter.Your blood clotting time (called PT INR) is within a certain range.My high blood pressure is well controlled with stable medication.My child can do most activities but may need help.You have low levels of protein in your urine.Your platelet count is at least 100,000 per microliter.Your absolute neutrophil count is at least 1,000 per microliter.You are allergic to Chinese hamster ovary cell products or other genetically engineered human antibodies.I can take care of myself but might not be able to do heavy physical work.I am over 16 and can do most activities without help.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (temozolomide, Phase II Arm B)
- Group 2: Arm V (vorinostat/bevacizumab, Phase 3, Chemoradiotherapy)
- Group 3: Arm I (vorinostat, Phase II Arm A)
- Group 4: Arm III (Bevacizumab, Phase II Arm)
- Group 5: Arm IV (temozolomide, Phase 3 Arm B)
- Group 6: Feasibility (vorinostat)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this research been conducted before?
"Since 2002, Vorinostat has been the subject of clinical trials. The first study was conducted by Schering-Plough and involved 60 patients. After the initial study, Phase 2 drug approval was received in 2002. There are presently 610 active trials for Vorinostat being conducted across 2063 cities and 66 countries."
Answered by AI
How many people are currently signed up for this clinical trial?
"This study is not open for recruitment at the moment. The clinical trial was first posted on 2010-11-15 and was last edited on 2022-10-15. However, there are 408 other trials related to neoplasms and 610 studies concerning Vorinostat that are actively recruiting participants."
Answered by AI
Are patients being recruited for this research project at this time?
"This specific clinical trial is no longer looking for patients. The study was originally posted on November 15th, 2010 and updated for the last time on October 15th, 2020. There are currently 610 trials involving Vorinostat and 408 studies concerning neoplasms that have open recruitment."
Answered by AI
Is this research project only testing individuals who are 18 or older?
"The age range that this study is recruiting for begins at 3 years old and ends when the patient reaches 21 years old."
Answered by AI
For what reason is Vorinostat most commonly prescribed?
"Vorinostat is the go-to treatment for progression disease. However, it can also ameliorate symptoms in patients with malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and progressive cutaneous t-cell lymphoma."
Answered by AI
Who meets the eligibility requirements for participating in this research?
"This research is looking for 101 individuals, aged 3-21, who have neoplasms. To be eligible, participants must also meet the following conditions: They cannot have oligodendroglioma oroligoastrocytoma and their ECOG performance status (PS) must be 0-2."
Answered by AI
At how many locations is this experiment being conducted?
"There are 100 enrolment sites for this clinical trial, which can be found in cities such as Grand Rapids, Summit and Oakland. If you decide to participate in the study, try selecting a location that is closest to you to limit travel time and costs."
Answered by AI
Could you please summarize the findings of other scientific research on Vorinostat?
"Vorinostat was initially studied in 2002 at Memorial Sloan Kettering Cancer Center. Since that time, 1396 similar trials have completed. As of right now, there are 610 active trials taking place-- many of which are based in Grand Rapids, Michigan."
Answered by AI
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