Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002876
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
1999-11-01
Brief Title:
Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A PHASE II TRIAL OF ETOPOSIDE AND CISPLATIN IN THE TREATMENT OF RECURRENT EPENDYMOMAS
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with recurrent ependymomas following radiation therapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with recurrent ependymomas following radiation therapy
Detailed Description:
OBJECTIVES I Assess the efficacy and toxicity of etoposide and cisplatin in patients with recurrent ependymomas
OUTLINE All patients receive cisplatin followed by etoposide on days 1-3 Treatment repeats every 4 weeks for a total of 6 courses unless disease progression or unacceptable toxicity intervenes The etoposide dose may be increased by 10 on subsequent courses if the white blood cell and platelet nadirs on the previous course are at least 3000 and 100000 respectively Patients are followed every 2 months for 6 months then every 3 months for 45 years
PROJECTED ACCRUAL A total of 35 patients will be entered over approximately 7 years if there are 3-8 responses in the first 13 patients and 7-9 responses in the first 25 patients
OUTLINE All patients receive cisplatin followed by etoposide on days 1-3 Treatment repeats every 4 weeks for a total of 6 courses unless disease progression or unacceptable toxicity intervenes The etoposide dose may be increased by 10 on subsequent courses if the white blood cell and platelet nadirs on the previous course are at least 3000 and 100000 respectively Patients are followed every 2 months for 6 months then every 3 months for 45 years
PROJECTED ACCRUAL A total of 35 patients will be entered over approximately 7 years if there are 3-8 responses in the first 13 patients and 7-9 responses in the first 25 patients
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 |
|---|---|---|---|
| 394-91 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| 907253 | OTHER | None | None |
| V96-1072 | OTHER | None | None |