Repeat Radiation, Minocycline and Bevacizumab in Patients With Recurrent Glioma (RAMBO)
The primary objective of step 1 is the rate of adverse events of minocycline and bevacizumab during reirradiation and of step 2 is the response rate to bevacizumab, reirradiation, and minocycline. The secondary objectives are the response rate, PFS-3, PFS-6, and effects on quality of life and cognition from repeat radiation and bevacizumab.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1b/2 Study of Repeat rAdiation, Minocycline, and Bevacizumab in Patients With Recurrent gliOma (RAMBO)|
- Rate of Adverse Events [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]Rate of adverse events of minocycline and bevacizumab during reirradiation
- Response rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]Response rate to bevacizumab, reirradiation, and minocycline
- Quality of Life [ Time Frame: 30 months ] [ Designated as safety issue: No ]Effects on quality of life from repeat radiation and bevacizumab
- Cognitive effects [ Time Frame: 30 months ] [ Designated as safety issue: No ]Effects on cognition from repeat radiation and bevacizumab
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: All patients
All patients enrolled in study.
This is an open-label, multi-agent design. Bevacizumab will be administered in accordance with the FDA-approved dose for gliomas, 10mg/kg IV every 2 weeks. Bevacizumab will be continued every two weeks as long as tolerated. One cycle of bevacizumab will be 28 days, with treatments on day1 and day 15. Blood pressure, CBC, CMP, and urine protein level, either by UA or urine protein/creatinine ratio will be checked at the beginning of each cycle.
Other Name: AvastinDrug: Minocycline
Minocycline will be given by mouth twice a day starting at about half of the monotherapy maximal tolerated dose, 100 mg PO BID. Minocycline will be started on the day prior to radiation and continued until progression or intolerance. During the combined radiation, minocycline, and bevacizumab treatment, patients will be seen weekly with a CBC, CMP, and adverse event monitoring.Radiation: Radiation
Radiation planning will be individualized by the radiation oncologist based on the location of the current radiation field relative to prior radiation doses. The length and fractionation will be determined individually by the radiation oncologist.
After providing informed consent, patients will undergo screening for eligibility to participate in the study. Screening will start within 21 days prior to dosing.
Subjects will have an MRI within 21 days of starting radiation. QOL and cognition measures will be performed within 21 days of starting radiation. Radiation will be given with parameters determined on an individual basis by the radiation oncologist. Bevacizumab will be continued at 10mg/kg IV every 2 weeks. Minocycline will be given twice a day starting at 100mg PO BID. MRI, QOL, and cognitive tests will be obtained 1, 3 and 6 months after the end of radiation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580969
|Contact: Britney Hallfirstname.lastname@example.org|
|Contact: Amiee Maxwellemail@example.com|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|