A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas (NCT00526812) | Clinical Trial Compass
CompletedPhase 1
A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas
United States54 participantsStarted 2005-11-30
Plain-language summary
This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Prior histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligo-astrocytoma, glioblastoma multiforme, or gliosarcoma, for whom no other effective therapy is available.
* A prior histologic diagnosis of a lower grade of glioma is allowed if there is current histologic proof of progression to a diagnosis of AA, AO, AOA, GBM or GS
* Unequivocal evidence of recurrence or progression by neuroimaging procedure.
* Surgical resection at least 2 weeks prior to enrollment and must have completely recovered from the side effects.
* A stable dose of steroids for at least 7 days prior to obtaining the Gd-MRI of the brain.
* Previously implanted Gliadel® wafer may be eligible.
* Karnofsky Performance Status (KPS) of ≥ 60.
* Laboratory parameters: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 9 g/dl, Platelets ≥ 100 x 109/L, AST and ALT ≤ 3.0 x Upper Limit of Normal (ULN), Serum bilirubin ≤ 1.5 x ULN, Serum creatinine ≤ 1.5 x ULN and 24 hour creatinine clearance ≥ 50 ml/min
* Life expectancy of greater than 12 weeks.
* Written informed consent obtained.
Exclusion Criteria:
* Pregnancy or breast feeding, or adults of reproductive potential not employing an effective method of birth control
* Total urinary protein in 24 hours urine collection \> 500 mg
* Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study.
* Impaired cardiac function, other signif…
What they're measuring
1
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of RTA 744 Injection in the patient population studied and to determine the qualitative and quantitative toxic effects of RTA 744 Injection.
Timeframe: at end of first cycle for each patient cohort