Bevacizumab and Ascorbic Acid in Patients Treating With Recurrent High Grade Glioma

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT02833701
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ascorbic Acid — DIETARY_SUPPLEMENT
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given intravenously (IV)
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

This phase I trial studies the side effects and best dose of ascorbic acid when given together with bevacizumab in treating patients with high grade glioma that has come back (recurrent). Monoclonal antibodies, such as bevacizumab may interfere with the ability of tumor cells to grow and spread. Ascorbic acid contains ingredients that may prevent or slow the growth of high grade glioma. Giving bevacizumab and ascorbic acid together may work better in treating patients with high grade glioma.

Key Dates

First listed
Jul 14, 2016
Start date
Mar 31, 2016
Status verified
Oct 2023
Primary completion
Mar 31, 2019
Completion
Mar 31, 2019

Study Design

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

Arms

  • Experimental: Treatment (bevacizumab and ascorbic acid)
    Patients receive ascorbic acid IV over 90-120 minutes three times per week (at least 24 hours apart) and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Frequency of occurrence of overall toxicity [ Time Frame: Up to 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-

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