Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01017653
Status:
TERMINATED
Last Update Posted:
2013-09-04
First Post:
2009-11-19
Brief Title:
Panitumumab and Irinotecan for Malignant Gliomas
Sponsor:
Annick Desjardins
Organization:
Duke University
Study Overview
Official Title:
Phase II Study of Panitumumab in Combination With Irinotecan for Malignant Gliomas
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study did not reach benchmark efficacy rule at 16 subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II study of the combination of panitumumab with irinotecan in malignant glioma patients The primary objective of the study is to determine the activity of the combination of panitumumab with irinotecan as measured by 6-month progression-free survival Secondary objectives include the following- to determine the safety of panitumumab in combination with irinotecan in patients with malignant glioma to determine the effect of panitumumab in combination with irinotecan on corticosteroid dose for each patient to explore any relationship between epidermal growth factor receptor EGF-R mutational analysis and efficacy or toxicity and to determine the response rate and overall survival of recurrent glioblastoma GBM patients treated with panitumumab in combination with irinotecan
The patients will have histologically documented grade 4 malignant gliomas glioblastoma multiforme or gliosarcoma that have failed at least one prior chemotherapy regimen and all patients will have received radiation therapy This study will investigate second or greater line of therapy for recurrent grade 4 malignant glioma The patient population will include 32 patients
The patients will undergo a baseline magnetic resonance imaging MRI as well as a MRI after every six-week cycle to determine response and progression After 16 patients with recurrent GBM are treated an interim analysis will be conducted The most common side effects associated with panitumumab have been dermatological skin problems such as erythema redness of the skin acneiform rash skin eruptions of the face skin exfoliation pruritus itching skin fissures skin tears xerosis dryness of the eye skin or mouth and rash The most common side effects associated with irinotecan have been decreased blood counts of platelets increased risk of bleeding white blood cells increased risk of infection red blood cells anemia diarrhea constipation nausea vomiting tiredness fever mouth sores dehydration excessive loss of body fluids rash itching changes in skin color swelling numbness tingling dizziness confusion low blood pressure sweating hot flashes hair loss inflammation of the liver flu-like symptoms decreased urine output shortness of breath and pneumonia inflammatory disease of the lungs
The patients will have histologically documented grade 4 malignant gliomas glioblastoma multiforme or gliosarcoma that have failed at least one prior chemotherapy regimen and all patients will have received radiation therapy This study will investigate second or greater line of therapy for recurrent grade 4 malignant glioma The patient population will include 32 patients
The patients will undergo a baseline magnetic resonance imaging MRI as well as a MRI after every six-week cycle to determine response and progression After 16 patients with recurrent GBM are treated an interim analysis will be conducted The most common side effects associated with panitumumab have been dermatological skin problems such as erythema redness of the skin acneiform rash skin eruptions of the face skin exfoliation pruritus itching skin fissures skin tears xerosis dryness of the eye skin or mouth and rash The most common side effects associated with irinotecan have been decreased blood counts of platelets increased risk of bleeding white blood cells increased risk of infection red blood cells anemia diarrhea constipation nausea vomiting tiredness fever mouth sores dehydration excessive loss of body fluids rash itching changes in skin color swelling numbness tingling dizziness confusion low blood pressure sweating hot flashes hair loss inflammation of the liver flu-like symptoms decreased urine output shortness of breath and pneumonia inflammatory disease of the lungs
Detailed Description:
None
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