A Safety Study of RTA 744 in Recurrent, Progressive or Refractory Neoplastic Meningitis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent neoplastic meningitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reata Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Histologic confirmation of primary malignancy. All primary tumor types may be enrolled.

• Neoplastic meningitis/leptomeningeal metastasis refractory to conventional therapy with presence of tumor cells on cytology, OR neuroimaging evidence of leptomeningeal tumor by MRI.

• Not eligible for higher priority clinical trial.

• Have recovered from side effects of any surgical resection.

• A stable dose of steroid for at least 7 days prior to the Gd-MRI.

• Karnofsky Performance Status (KPS) of ≥ 60.

• Laboratory Parameters: ANC ≥ 1.5 x 109/L; Hgb ≥ 9 g/dl; Platelets ≥ 100 x 109/L; AST and ALT ≤ 3.0 x ULN; Serum bilirubin ≤ 1.5 x ULN; Serum creatinine ≤ 1.5 x ULN; 24 hour creatinine clearance ≥ 50 ml/min

• Life expectancy of at least 8 weeks.

• Written informed consent obtained.

Exclusion Criteria:

• Concurrent therapy for leptomeningeal disease or other malignancy.

• Clinical evidence of obstructive hydrocephalus or compartmentalization of CSF flow.

• Cumulative doses: doxorubicin > 450 - 550 mg/m2, epirubicin > 800-1000 mg/m2, idarubicin >130-150 mg/m2 and daunorubicin > 400-550 mg/m2.

• Anticonvulsant medications or other types of medications which are known to induce the CYP450 enzymes.

• Pregnancy or breast feeding, or adults (male or female) of reproductive potential not employing an effective method of birth control

• Total 24 hour urinary protein > 500 mg.

• 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 type

• Myocardial infarction ≤ 6 months prior

• History of CHF or arrhythmias

• Therapeutic doses of anticoagulant therapy (prophylactic dosing is allowed)

• Investigational drugs less than 4 weeks prior; intrathecal chemotherapy within 2 weeks prior; systemic cytotoxic chemotherapy within 4 weeks prior (6 weeks for nitrosourea or mitomycin-C or 2 weeks for vincristine); radiation therapy within 2 weeks prior; any medication known to cause QT interval prolongation

• Any surgery <2 weeks prior