Repeat Radiation, Minocycline and Bevacizumab in Patients With Recurrent Glioma

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT01580969
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Recurrent Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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.
  • Minocycline — DRUG
    Minocycline will be given by mouth twice a day at the assigned dose level. Minocycline will be started on the day prior to radiation and continued until progression or intolerance.
  • 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.

Study Details

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, Progression Free Survival (PFS)-3, PFS-6, and effects on quality of life and cognition from repeat radiation and bevacizumab.

Key Dates

First listed
Apr 19, 2012
Start date
Jul 6, 2012
Status verified
Aug 2019
Primary completion
Jan 12, 2018
Completion
May 15, 2018

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 0: 100 mg bid
    Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
  • Experimental: Dose Level 1: 200 mg bid
    Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
  • Experimental: Dose Level 2: 400 mg bid
    Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From first dose of study treatment to 28 days following radiation therapy (7-8 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112-

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By research site
Huntsman Cancer Institute· Salt Lake City, UT

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