Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors
NCT00075387 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2022-05-03
Summary
This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.
Conditions
- Malignant Glioma
Interventions
- DRUG
-
Given IA
- DRUG
-
Given IV
- DRUG
-
Etoposide Phosphate
Given IV
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- DRUG
-
Sodium Thiosulfate
Given IV
Sponsors & Collaborators
-
Oregon Health and Science University
collaborator OTHER -
OHSU Knight Cancer Institute
lead OTHER
Principal Investigators
-
Edward A Neuwelt · OHSU Knight Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-07
- Primary Completion
- 2023-04-30
- Completion
- 2024-04-30
Countries
- United States
Study Locations
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