A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas

NCT00526812 | Completed Phase 1

• 1 other identifier: RTA 744-C-0401
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.

Conditions

Glioma

Outcome Measures

Primary Outcomes (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.

  at end of first cycle for each patient cohort

Secondary Outcomes (1)

• To characterize the multiple-dose pharmacokinetics of RTA 744 and to document any potential antitumor activity of RTA 744 in those patients with measurable disease.

  end of study

Study Arms (2)

Group A (RTA 744)

EXPERIMENTAL

Receive study drug for three consecutive days, Cycle repeated every 21 days.

Drug: RTA 744

Group C (RTA 744 Injection)

EXPERIMENTAL

Receive study drug once a week for four consecutive weeks. Repeat cycle every 5 weeks.

Drug: RTA 744 injection

Interventions

RTA 744 DRUG

Aqueous solution added to 10%D/W and infused over 2 hours on three consecutive days. 5 mg vials contain 1 mg/ml.

Group A (RTA 744)

RTA 744 injection DRUG

Aqueous solution in 1mg/ml. Doses are escalated. Drug is infused intravenously over 2 hours one day a week for four consecutive weeks.

Group C (RTA 744 Injection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 significant prior cardiac disease or arrhythmia of any
• A history of CHF or arrhythmias.
• Therapeutic doses of warfarin sodium (Coumadin®).
• Prior or concurrent therapy, or not recovered from the toxic effects of such therapy: investigational drugs, chemotherapy, metronomic daily dosing of chemotherapy agents, biologic, immunotherapy or cytostatic agents within 4 weeks prior to study entry; radiation therapy within 2 weeks prior to study entry, any medication known to cause QT interval prolongation
• Any surgery other than resection of a brain tumor within 2 weeks prior to enrollment.
• A contraindication to MRI imaging.

Sponsors & Collaborators

• Biogen: lead

Study Sites (4)

UCLA School of Medicine, Department of Neurology

Los Angeles, California, 90095, United States

Location

Baylor University Medical Center: Neuro-Oncology Associates

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75309, United States

Location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

WP 744

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 10, 2007
• Study Start: November 30, 2005
• Primary Completion: December 1, 2008
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (4)