IRB #

IRB00000922

Title

Phase II Clinical Trial of Patients with High-Grade Glioma Treated with Intra-arterial Carboplatin-based Chemotherapy, Randomized to Treatment with or without Delayed Intravenous Sodium Thiosulfate as a Potential Chemoprotectant against Severe Thrombocytopenia

Principal Investigator

Edward Neuwelt

Study Purpose

The purpose of this study is to evaluate if the drug called sodium thiosulfate prevents a severe decrease in a particular type of blood cell (platelets) in patients who are being given carboplatin, cyclophosphamide, and etoposide phosphate for the treatment of high-grade glioma. This is a randomized study meaning that neither the participant nor their doctor may choose to which treatment group the participant is assigned. All participants of this study receive the chemotherapy drugs carboplatin (intra-arterial), cyclophosphamide (intravenous) and etoposide phosphate (intravenous). Participants will be randomized in two groups. Group 1 will receive the chemotherapy drugs, but not the sodium thiosulfate. Group 2 will receive the chemotherapy drugs, followed by the sodium thiosulfate (intravenous), four and eight hours after the chemotherapy.

Medical Condition(s)

Brain & Nervous System

Eligibility Criteria

High-grade glioma
Age 18 to 75 years old

Age Range

18 - 75

Healthy Volunteers Needed

No

Duration of Participation

Minors Included

No

Contact

Edward A Neuwelt, MD 503-494-5626 neuwelte@ohsu.edu

Sponsor

NIH

Recruitment End

Compensation Provided

No