A PHASE I DOSE ESCALATION STUDY OF HYPOFRACTIONATED STEREOTACTIC RADIOTHERAPY WITH BEVACIZUMAB IN THE TREATMENT OF RECURRENT MALIGNANT GLIOMA
Sponsor study identifier
interventional
15
1 country
5
Study Start
July 8, 2011
Actual (reported)Primary Completion
November 15, 2019
Actual (reported)Study Completion
November 15, 2019
Actual (reported)The best dose of radiation to be given with bevacizumab is currently unknown. This study will use higher doses of radiation with bevacizumab than have been used before. This study will test the safety of radiation given at different doses with bevacizumab to find out what effects, good and/or bad, it has on the patient and the malignant glioma or related brain cancers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 8, 2011
Actual (reported)July 8, 2011
Actual (reported)July 12, 2011
Actual (reported)November 15, 2019
Actual (reported)November 15, 2019
Actual (reported)To establish the maximum tolerated dose (MTD)
of hypofractionated stereotactic re-irradiation delivered with concomitant bevacizumab in recurrent malignant gliomas (using a standard 3+3 design).
1 year
Response rate
1 year
Median progression free survival
1 year
This will be a multicenter (MSKCC and UCSF) phase I dose escalation study to determine the maximum tolerated dose (MTD) of hypofractionated stereotactic radiotherapy when administered in combination with a fixed dose of bevacizumab.
Treatment: (until treatment failure): bevacizumab 10 mg/kg IV once every two weeks on days 1 (+/- 3 days) and 15 (+/- 3 days) of every cycle (Cycle defined as 28 days). On day 28 (or up to 2 days before) of cycles 1 and 2 (and for every other cycle thereafter) patients will undergo a physical and radiological re-evaluation (MRI). Patients will begin stereotactic radiotherapy beginning anywhere from day 7 to day 10 of cycle 2 with escalating fraction sizes (interpatient - there is no intrapatient escalation). Assessment of response will be performed following cycles 1 and 2 then following every two cycles.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment and procedure
Bevacizumab & Stereotactic Radiotherapy
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry recordUniversity of California San Francisco
San Francisco, California, 94143, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Clarke J, Neil E, Terziev R, Gutin P, Barani I, Kaley T, Lassman AB, Chan TA, Yamada J, DeAngelis L, Ballangrud A, Young R, Panageas KS, Beal K, Omuro A. Multicenter, Phase 1, Dose Escalation Study of Hypofractionated Stereotactic Radiation Therapy With Bevacizumab for Recurrent Glioblastoma and Anaplastic Astrocytoma. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):797-804. doi: 10.1016/j.ijrobp.2017.06.2466. Epub 2017 Jun 30.
Thomas Kaley, MD
Memorial Sloan Kettering Cancer Center
15 participants (actual enrollment reported by the registry).
First Submitted
July 8, 2011
First Posted
July 12, 2011
Study Start
July 8, 2011
Actual (reported)Primary Completion
Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
6 month progression-free survival rate
1 year
Median overall survival
1 year
Use of tractography to predict routes of progression in gliomas (MSKCC only)
1 year
Contact the study team to confirm eligibility.
November 15, 2019
Actual (reported)Study Completion
November 15, 2019
Actual (reported)Last Updated
November 22, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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