Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238173
Status:
TERMINATED
Last Update Posted:
2017-04-21
First Post:
2005-10-12
Brief Title:
Acetylcysteine Mannitol Combination Chemotherapy and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase I Dose Escalation Study of N-Acetylcysteine Administered in Conjunction With Carboplatin Cyclophosphamide and Etoposide Phosphate BBBD in Children With Malignant Brain Tumors
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
OHSU IRB closed study to further enrollment 2172006
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as cyclophosphamide etoposide phosphate and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Mannitol may help chemotherapy work better by making it easier for these drugs to get to the tumor Chemoprotective drugs such as acetylcysteine and sodium thiosulfate may protect normal cells from the side effects of chemotherapy Giving acetylcysteine together with mannitol combination chemotherapy and sodium thiosulfate may be an effective treatment for malignant brain tumors
PURPOSE This phase I trial is studying the side effects and best dose of acetylcysteine when given together with mannitol combination chemotherapy and sodium thiosulfate in treating children with malignant brain tumors
PURPOSE This phase I trial is studying the side effects and best dose of acetylcysteine when given together with mannitol combination chemotherapy and sodium thiosulfate in treating children with malignant brain tumors
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity and maximum tolerated dose of acetylcysteine when given in combination with blood-brain barrier disruption treatment with mannitol combination chemotherapy comprising cyclophosphamide etoposide phosphate and carboplatin and delayed high-dose sodium thiosulfate in pediatric patients with malignant brain tumors
Secondary
Determine the bloodbone marrow toxicity of this regimen in these patients
Determine tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study of acetylcysteine
Patients receive acetylcysteine IV over 30-60 minutes followed at least 15 minutes later by x-ray-guided femoral artery catheterization under general anesthesia on days 1 and 2 After placement of the catheter patients receive cyclophosphamide IV over 10 minutes etoposide phosphate IV over 10 minutes mannitol intra-arterially IA over 30 seconds and carboplatin IA over 10 minutes also on days 1 and 2 Patients then receive high-dose sodium thiosulfate IV over 15 minutes 4 hours after completion of carboplatin Some patients may receive a second dose of sodium thiosulfate 8 hours after completion of carboplatin Beginning 48 hours after the last dose of chemotherapy on day 2 patients receive filgrastim G-CSF subcutaneously once daily for 7-10 days or until blood counts recover Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of acetylcysteine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 3 patients are treated at the MTD
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the toxicity and maximum tolerated dose of acetylcysteine when given in combination with blood-brain barrier disruption treatment with mannitol combination chemotherapy comprising cyclophosphamide etoposide phosphate and carboplatin and delayed high-dose sodium thiosulfate in pediatric patients with malignant brain tumors
Secondary
Determine the bloodbone marrow toxicity of this regimen in these patients
Determine tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study of acetylcysteine
Patients receive acetylcysteine IV over 30-60 minutes followed at least 15 minutes later by x-ray-guided femoral artery catheterization under general anesthesia on days 1 and 2 After placement of the catheter patients receive cyclophosphamide IV over 10 minutes etoposide phosphate IV over 10 minutes mannitol intra-arterially IA over 30 seconds and carboplatin IA over 10 minutes also on days 1 and 2 Patients then receive high-dose sodium thiosulfate IV over 15 minutes 4 hours after completion of carboplatin Some patients may receive a second dose of sodium thiosulfate 8 hours after completion of carboplatin Beginning 48 hours after the last dose of chemotherapy on day 2 patients receive filgrastim G-CSF subcutaneously once daily for 7-10 days or until blood counts recover Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of acetylcysteine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 3 patients are treated at the MTD
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| OHSU-IRB-2050 | None | None | None |
| OHSU-8522 | None | None | None |
| OHSU-SOL-04085-L | None | None | None |