TriangleNCT00345163 · CITED IN SOURCE DOCUMENTS
A Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-05-16
This is a Phase II, open-label, multicenter, randomized, non comparative study consisting of two concurrent single-arms. Approximately 160 subjects will be randomized in a 1:1 ratio to Arm 1 (bevacizumab alone) or Arm 2 (bevacizumab + irinotecan).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Signed Informed Consent Form * Age ≥ 18 years * Histologically confirmed GBM in first or second relapse * Radiographic demonstration of disease progression following prior therapy * Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on MRI performed within 14 days prior to first treatment (Day 0) * An interval of ≥ 4 weeks since prior surgical resection * Prior standard radiation for GBM * Prior chemotherapy: first-relapse subjects * Prior chemotherapy: second-relapse subjects * Recovery from the effects of prior therapy, including the following: 4 weeks from cytotoxic agents (except 6 weeks from nitrosoureas, 3 weeks from procarbazine, 2 weeks from vincristine); 4 weeks from any investigational agent; 1 week from non-cytotoxic agents; 8 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field * Prior therapy with gamma knife or other focal high-dose radiation is allowed but the subject must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field * Karnofsky performance status ≥ 70 * Life expectancy \> 12 weeks * Use of an effective means of contraception in males and in females of childbearing potential * Ability to comply with study and follow-up procedures Exclusion Criteria: * Prior treatment with irinotecan, bevacizumab, or another VEGF or VEGFR-targeted agent * Prior treatment with prolifeprospan 20 with carmustine wafer * Prior intracerebral agents * Need for urgent palliative intervention for primary disease (e.g., impending herniation) * Evidence of recent hemorrhage on baseline MRI of the brain with the following exceptions: Presence of hemosiderin; Resolving hemorrhagic changes related to surgery; Presence of punctate hemorrhage in the tumor * Received more than two treatment regimens for Grade III and/or Grade IV glioma * Blood pressure of \> 150 mmHg systolic and \> 100 mmHg diastolic * History of hypertensive encephalopathy * New York Heart Association (NYHA) Grade II or greater CHF * History of myocardial infarction or unstable angina within 6 months prior to Day 0 * History of stroke or transient ischemic attack within 6 months prior to study enrollment * Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 0 * Evidence of bleeding diathesis or coagulopathy * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 * History of intracerebral abscess within 6 months prior to Day 0 * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study * Minor surgical procedures (excluding placement of a vascular access device), stereotactic biopsy, fine needle aspirations, or core biopsies within 7 days prior to Day 0 * Serious non-healing wound, ulcer, or bone fracture * Pregnancy (positive pregnancy test) or lactation * Known hypersensitivity to any component of bevacizumab * History of any other malignancy within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix) * Pregnant or nursing females * Unstable systemic disease, including active infection, uncontrolled hypertension, or serious cardiac arrhythmia requiring medication * Subjects unable to undergo an MRI with contrast
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: bevacizumab
- label
- 1
- type
- EXPERIMENTAL
- intervention Names
- Drug: bevacizumab
- Drug: irinotecan
- label
- 2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 1
- 2
- description
- Intravenous repeating dose
- name
- bevacizumab
- type
- DRUG
- arm Group Labels
- 2
- description
- Intravenous repeating dose
- name
- irinotecan
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 167
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Objective response, as determined by the independent review facility (IRF)
- time Frame
- Complete response or partial response, determined on two consecutive assessments ≥4 weeks apart
- measure
- Progression-free survival, as determined by the IRF
- time Frame
- 6 months
- secondary Outcomes
- measure
- Incidence of adverse events and serious adverse events
- time Frame
- Length of patient on study
- measure
- Duration of objective response, as determined by the IRF
- time Frame
- Complete or partial response determined on two consecutive assessments ≥4 weeks apart
- measure
- Overall survival
- time Frame
- Time from randomization to death
Full study description
- brief Summary
- This is a Phase II, open-label, multicenter, randomized, non comparative study consisting of two concurrent single-arms. Approximately 160 subjects will be randomized in a 1:1 ratio to Arm 1 (bevacizumab alone) or Arm 2 (bevacizumab + irinotecan).
Source references
- references
- citation
- Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, Yung WK, Paleologos N, Nicholas MK, Jensen R, Vredenburgh J, Huang J, Zheng M, Cloughesy T. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009 Oct 1;27(28):4733-40. doi: 10.1200/JCO.2008.19.8721. Epub 2009 Aug 31.
- pmid
- 19720927
- type
- RESULT
- citation
- Ellingson BM, Hagiwara A, Morris CJ, Cho NS, Oshima S, Sanvito F, Oughourlian TC, Telesca D, Raymond C, Abrey LE, Garcia J, Aftab DT, Hessel C, Rachmilewitz Minei T, Harats D, Nathanson DA, Wen PY, Cloughesy TF. Depth of Radiographic Response and Time to Tumor Regrowth Predicts Overall Survival Following Anti-VEGF Therapy in Recurrent Glioblastoma. Clin Cancer Res. 2023 Oct 13;29(20):4186-4195. doi: 10.1158/1078-0432.CCR-23-1235.
- pmid
- 37540556
- type
- DERIVED
- citation
- Ellingson BM, Harris RJ, Woodworth DC, Leu K, Zaw O, Mason WP, Sahebjam S, Abrey LE, Aftab DT, Schwab GM, Hessel C, Lai A, Nghiemphu PL, Pope WB, Wen PY, Cloughesy TF. Baseline pretreatment contrast enhancing tumor volume including central necrosis is a prognostic factor in recurrent glioblastoma: evidence from single and multicenter trials. Neuro Oncol. 2017 Jan;19(1):89-98. doi: 10.1093/neuonc/now187. Epub 2016 Aug 31.
- pmid
- 27580889
- type
- DERIVED
- citation
- Ellingson BM, Kim HJ, Woodworth DC, Pope WB, Cloughesy JN, Harris RJ, Lai A, Nghiemphu PL, Cloughesy TF. Recurrent glioblastoma treated with bevacizumab: contrast-enhanced T1-weighted subtraction maps improve tumor delineation and aid prediction of survival in a multicenter clinical trial. Radiology. 2014 Apr;271(1):200-10. doi: 10.1148/radiol.13131305. Epub 2013 Nov 27.
- pmid
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- type
- DERIVED
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Preserved source evidence · Not medical advice