Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003134
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Recurrent Glioma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Irinotecan in Recurrent Glioma
Status:
COMPLETED
Status Verified Date:
2016-12
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
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent glioma
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent glioma
Detailed Description:
OBJECTIVES I Determine the efficacy of irinotecan in the treatment of patients with recurrent glioma II Assess the toxicities of irinotecan in these patients III Correlate the pharmacological parameters with toxicity and response to therapy
OUTLINE This is a two arm study Patients are stratified according to prior nitrosourea administration Patients are assigned to 1 of 2 arms with only 1 arm being open at any time Patients assigned to arm I receive irinotecan IV over 90 minutes on days 1 8 15 and 22 This is followed by a 2 week rest and continues for a maximum of 6 courses Patients assigned to arm II receive irinotecan on day 1 every 3 weeks for up to 12 courses Patients in both arms who received prior nitrosoureas receive reduced starting doses of irinotecan The dosages may be increased once per patient after the first course if toxic effects are acceptable Arm I closed as of 1098 Arm II open as of 1098 Patients are followed every 3 months for the first year every 6 months for the next 4 years then annually until death
OUTLINE This is a two arm study Patients are stratified according to prior nitrosourea administration Patients are assigned to 1 of 2 arms with only 1 arm being open at any time Patients assigned to arm I receive irinotecan IV over 90 minutes on days 1 8 15 and 22 This is followed by a 2 week rest and continues for a maximum of 6 courses Patients assigned to arm II receive irinotecan on day 1 every 3 weeks for up to 12 courses Patients in both arms who received prior nitrosoureas receive reduced starting doses of irinotecan The dosages may be increased once per patient after the first course if toxic effects are acceptable Arm I closed as of 1098 Arm II open as of 1098 Patients are followed every 3 months for the first year every 6 months for the next 4 years then annually until death
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 |
|---|---|---|---|
| CDR0000065900 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02257 | REGISTRY | None | None |