Status:
UNKNOWN
Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Malignant Glioma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 t...
Detailed Description
PRIMARY OBJECTIVE: I. Determine the effect of delayed administration of sodium thiosulfate on the rates of platelet toxicity (i.e. platelet count less than 20,000), in subjects with high-grade glioma...
Eligibility Criteria
Inclusion
- Subjects with histologically confirmed high-grade glioma are eligible; diagnosis of high-grade glioma will be made on the basis of needle biopsy, open biopsy, or surgical resection
- Subjects may have had prior focal or systemic radiation or chemotherapy; at least 14 days must have elapsed since radiation treatment and 28 days since prior chemotherapy
- Performance status (Eastern Cooperative Oncology Group \[ECOG\]) must be less than or equal to 2 (Karnofsky greater than or equal to 50)
- White blood cell count \>= 2.5 x 10\^3/mm\^3
- Absolute granulocyte count \>= 1.2 x 10\^3/mm\^3
- Platelets \>= 100 x 10\^3/mm\^3
- Creatinine \< 1.8
- Bilirubin \< 2.0
- Baseline aspartate aminotransferase (AST)/alanine aminotransferase (ALT) serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) must be \< 2.5 x institutional upper limits of normal
- Subject (or legal guardian) must sign a written informed consent in accordance with institutional guidelines
- Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study treatment and for the duration of study treatment; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform the investigator
Exclusion
- Subjects with rapidly progressing central nervous system (CNS) disease with associated neurological deterioration
- Subjects with uncontrolled (over the last 30 days) clinically significant confounding medical conditions such as congestive heart failure
- Subjects who are pregnant, have a positive serum human chorionic gonadotropin (hCG) or are lactating
- Subjects who have contraindications to carboplatin, cyclophosphamide, etoposide phosphate, or sodium thiosulfate
Key Trial Info
Start Date :
March 7 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00075387
Start Date
March 7 2003
End Date
April 30 2024
Last Update
May 3 2022
Active Locations (3)
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1
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
2
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
3
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239