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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.
Full description
The phase I part of the study will be completed to determine the Maximum Tolerated Dose (MTD) of high-dose L-methylfolate in combination with bevacizumab at 10mg/kg IV every 14 days, a 5-day regimen per month of temozolomide at 150 mg/m2/day and a 250 mg tablet of vitamin C. Dose escalation will involve 3 patients treated at each dose level of L-methylfolate (15mg, 30 mg, 60 mg or 90 mg), and the MTD will be confirmed by expansion of 3 additional patients. It is anticipated that 6 to 15 patients will be enrolled in the phase 1 part of the study. Patients will continue treatment until disease progression. Once the MTD of L-methylfolate has been determined, patients enrolled at a lower dose level may increase L-methylfolate dose to the MTD dose, per investigator discretion.
The phase II part of the study will consist of patients taking the MTD of L-methylfolate daily in combination with bevacizumab at 10 mg/kg IV every 14 days, a 5-day regimen per month of temozolomide at 150 mg/m2/day and a 250 mg tablet of vitamin C. There will be 32 patients treated in the Phase II study and the patients will continue treatment until progression. The 6 patients treated at the MTD cohort in Phase
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Inclusion criteria
leukocytes greater than or equal to 3,000/milliliter (mcL) absolute neutrophil count greater than or equal to 1,500/mcL platelets greater than or equal to 100,000/mcL total bilirubin within normal institutional limits Aspartate transaminase (serum glutamic oxaloacetic transaminase)Alanine transaminase (Serum Glutamic Pyruvate Transaminase) less than or equal to 2.5 times institutional upper limit of normal Creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60/mL/min 1.73 m2 for patients with creatinine levels above institutional normal
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14 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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