Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075387
Status:
UNKNOWN
Last Update Posted:
2022-05-03
First Post:
2004-01-09
Brief Title:
Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official 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
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
PRIMARY OBJECTIVE
I Determine the effect of delayed administration of sodium thiosulfate on the rates of platelet toxicity ie platelet count less than 20000 in subjects with high-grade glioma undergoing treatment with carboplatin cyclophosphamide and etoposideetoposide phosphate
SECONDARY OBJECTIVES
I Assess tumor response in subjects with high-grade glioma undergoing treatment with carboplatin cyclophosphamide and etoposideetoposide phosphate with or without delayed sodium thiosulfate
II Assess the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in subjects undergoing treatment with carboplatin cyclophosphamide and etoposideetoposide phosphate
III Assess hearing changes if any at the higher frequencies in the standard testing range 4000 and 8000 Hertz Hz and at higher frequencies above standard testing 9000 to 16000 Hz
IV Assess quality of life in subjects undergoing treatment with carboplatin cyclophosphamide and etoposide phosphate
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive cyclophosphamide intravenously IV etoposide phosphate IV and carboplatin intra-arterially IA over 10 minutes on day 1
ARM II Patients receive cyclophosphamide IV etoposide phosphate IV and carboplatin IA as in Arm I Patients also receive sodium thiosulfate IV over 15 minutes 4 and 8 hours after carboplatin
In both arms treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year every 6 months for 2 years and then annually thereafter
I Determine the effect of delayed administration of sodium thiosulfate on the rates of platelet toxicity ie platelet count less than 20000 in subjects with high-grade glioma undergoing treatment with carboplatin cyclophosphamide and etoposideetoposide phosphate
SECONDARY OBJECTIVES
I Assess tumor response in subjects with high-grade glioma undergoing treatment with carboplatin cyclophosphamide and etoposideetoposide phosphate with or without delayed sodium thiosulfate
II Assess the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in subjects undergoing treatment with carboplatin cyclophosphamide and etoposideetoposide phosphate
III Assess hearing changes if any at the higher frequencies in the standard testing range 4000 and 8000 Hertz Hz and at higher frequencies above standard testing 9000 to 16000 Hz
IV Assess quality of life in subjects undergoing treatment with carboplatin cyclophosphamide and etoposide phosphate
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive cyclophosphamide intravenously IV etoposide phosphate IV and carboplatin intra-arterially IA over 10 minutes on day 1
ARM II Patients receive cyclophosphamide IV etoposide phosphate IV and carboplatin IA as in Arm I Patients also receive sodium thiosulfate IV over 15 minutes 4 and 8 hours after carboplatin
In both arms treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year every 6 months for 2 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB00000922 | OTHER | OHSU IRB | None |
| NCI-2013-00781 | REGISTRY | None | None |
| eIRB 922 | OTHER | None | None |
| ONC-02019-L | OTHER | None | None |
| CR00023930 | OTHER | None | None |
| MR00041590 | OTHER | None | None |
| CR00021317 | OTHER | None | None |
| CR00018679 | OTHER | None | None |
| CR00022743 | OTHER | None | None |