A Phase I Study of High-dose L-methylfolate in Combination With Temozolomide and Bevacizumab in Recurrent High Grade Glioma

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT01891747
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Glioma

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    bevacizumab at 10mg/kg IV every 14 days (Phase I \& phase II)
  • Temozolomide — DRUG
    150 mg/m2/day for a 5-day regimen per month (Phase I \& Phase II)
  • Vitamin C — DIETARY_SUPPLEMENT
    250 mg vitamin C once a day (oral) - Phase I \& Phase II

Study Details

This is a Phase I/II non-randomized prospective study of high-dose L-methylfolate in combination with bevacizumab and temozolomide in patients with recurrent high-grade glioma. The primary objective of this phase II trial is to determine whether the addition of high-dose L-methylfolate to bevacizumab and temozolomide therapy improves progression-free survival (PFS) compared to previously reported results.

Key Dates

First listed
Jul 3, 2013
Start date
Jul 31, 2013
Status verified
Mar 2022
Primary completion
Jun 30, 2015
Completion
Jan 31, 2022

Study Design

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

Arms

  • Experimental: L-methylfolate with Bevacizumab & Temozolomide
    28-day cycle, dose levels L-methylfolate: Phase I 15 mg (once a day) 30 mg (15 mg twice a day) 60 mg (30 mg twice a day) 90 mg (45 mg twice a day) Phase II will use the MTD of L-methylfolate daily with bevacizumab \& temozolomide.

Primary Outcome Measure

Maximum Tolerated Dose (Phase I) [ Time Frame: every 4 weeks, 28-day cycle, up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

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By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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