Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

Sponsor
Huashan Hospital
Study ID
NCT02698280
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab is administered intravenously at 5mg/kg every 3 weeks.
  • Nimustine — DRUG
    Nimustine is administered intravenously at 90mg/m\^2 to 110mg/m\^2 every 6 weeks.

Study Details

The purpose of this study is to determine whether bevacizumab and nimustine are effective in the treatment of recurrent high grade glioma and to explore whether there is any subgroup being sensitive to this therapeutic protocol.

Key Dates

First listed
Mar 3, 2016
Start date
Jul 31, 2015
Status verified
Jul 2018
Primary completion
Jan 31, 2018
Completion
May 31, 2018

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Patients are treated with bevacizumab and nimustine. Every 6 weeks is defined as one therapeutic cycle. Adverse effect is evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.03). Hematologic toxicity is evaluated every 2 weeks. Liver function, renal function, and electrolytes are assessed every 4-6 weeks. Platelet should be no less than 100\*10\^9/L and neutrophil count should be no less than 1.5\*10\^9/L.

Primary Outcome Measure

All cause response to treatment [ Time Frame: 3 weeks ]

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