Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360828
Status:
TERMINATED
Last Update Posted:
2017-03-23
First Post:
2006-08-03
Brief Title:
Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas Mixed Malignant Gliomas and Oligodendrogliomas
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Study of Irinotecan HCI in Patients With Recurrent Anaplastic Astrocytomas Mixed Malignant Gliomas and Oligodendrogliomas
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator left Moffitt and study had low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 2 trial to explore the efficacy and safety of irinotecan CPT-11 Also administered at each cycle was zofranKytrilAnzemet decadron and IV atropine
At each cycle patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment Recorded past toxicities were to be compared with current side effects
At each cycle patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment Recorded past toxicities were to be compared with current side effects
Detailed Description:
Phase 2 trial to explore the efficacy and safety of irinotecan CPT-11 in patients with recurrent anaplastic astrocytomas AA mixed malignant glioma and oligodendrogliomas OA Patients were to be stratified by tumor histology and treated with CPT-11 every 21 days treatment cycle
Baseline data collected 14 days was to consist of a neurologicaloncological history neurological examination height weight performance status Quality Of Life FACT-L questionnaire laboratory studies to include complete blood count CBC differential platelets prothrombin time PT complete metabolic panel CMP Lactose dehydrogenase LDH and a pregnancy test as well as a cranial Computerized TomographyMagnetic Resonance Imaging CTMRI with and without contrast to measure or evaluate the size and location of the tumor before treatment
Administered every 21 days was a dose of irinotecan CPT-11 zofranKytrilAnzemet decadron and intravenous IV atropine At each cycle patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment Recorded past toxicities were to be compared with current side effects
Between days 15-21 within 7 days of next scheduled CPT-11 treatment the following tests were to be repeated - a neurologicaloncological history and neurological examination weight blood drawn CMP LDH performance status and Quality Of Life FACT-L questionnaire Also a MRI Cranial CTMRI with and without contrast was to be performed for tumor assessments at week 9 18 27 36 and after every nine weeks thereafter until progression Response was to be measured by a reduction in tumor size
These supportive therapies were provided as necessary
Antiemetic Therapy
Anticholinergics
Loperamide Imodium
Growth Factors
Other Concomitant Medications
Baseline data collected 14 days was to consist of a neurologicaloncological history neurological examination height weight performance status Quality Of Life FACT-L questionnaire laboratory studies to include complete blood count CBC differential platelets prothrombin time PT complete metabolic panel CMP Lactose dehydrogenase LDH and a pregnancy test as well as a cranial Computerized TomographyMagnetic Resonance Imaging CTMRI with and without contrast to measure or evaluate the size and location of the tumor before treatment
Administered every 21 days was a dose of irinotecan CPT-11 zofranKytrilAnzemet decadron and intravenous IV atropine At each cycle patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment Recorded past toxicities were to be compared with current side effects
Between days 15-21 within 7 days of next scheduled CPT-11 treatment the following tests were to be repeated - a neurologicaloncological history and neurological examination weight blood drawn CMP LDH performance status and Quality Of Life FACT-L questionnaire Also a MRI Cranial CTMRI with and without contrast was to be performed for tumor assessments at week 9 18 27 36 and after every nine weeks thereafter until progression Response was to be measured by a reduction in tumor size
These supportive therapies were provided as necessary
Antiemetic Therapy
Anticholinergics
Loperamide Imodium
Growth Factors
Other Concomitant Medications
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