Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396019
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2006-11-02
Brief Title:
Study of PEG-Intron for Plexiform Neurofibromas
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase II Trial of Peginterferon Alfa-2b PEG-Intron for Plexiform Neurofibromas
Status:
COMPLETED
Status Verified Date:
2017-10
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:
This study is for slow growing tumors called plexiform neurofibromas PNF which are a relatively common problem in people with neurofibromatosis type 1 NF1 These tumors are benign but as they grow they can become disfiguring as well as disabling or even life threatening They often cause pain difficulty using arms or legs because of spinal cord compression andor nerve damage At present the only available therapy for plexiform neurofibromas is to try to surgically remove as much of the tumor as is possible Because these tumors grow into the surrounding areas total surgical resection is often impossible Most tumors will re-grow after surgery if the entire tumor cannot be removed To date other treatments including chemotherapy and radiotherapy have not been able to shrink these tumors
Interferon is a drug that is used for different types of tumors as well as for hepatitis It has been used in the treatment of plexiform neurofibromas PNF with some subjects showing improvement in symptoms andor a decrease in the size of the tumor Most subjects had no further growth of their tumor while on the PEG-Intron The drug used in this study is PEG pegylated-Intron PEG-Intron is a long acting form of interferon which keeps the drug from being broken down in the body for a longer period of time and potentially could be more effective than the short-acting interferon PEG-Intron has been approved by the Food and Drug Administration FDA for the treatment of Hepatitis C
The goals of this study are
1 To determine how your childs plexiform neurofibroma responds to PEG-Intron when given weekly
2 To determine the side effects of PEG-Intron when given weekly to participants with plexiform neurofibromas
3 To evaluate a new method of measuring changes in the size of tumors called volume analysis This method measures the entire volume of a tumor in three dimensions The standard method of measuring tumors uses only the length andor width of the tumor By studying the different ways of measuring tumors the investigators hope to be able to determine which method is the most accurate and useful
Interferon is a drug that is used for different types of tumors as well as for hepatitis It has been used in the treatment of plexiform neurofibromas PNF with some subjects showing improvement in symptoms andor a decrease in the size of the tumor Most subjects had no further growth of their tumor while on the PEG-Intron The drug used in this study is PEG pegylated-Intron PEG-Intron is a long acting form of interferon which keeps the drug from being broken down in the body for a longer period of time and potentially could be more effective than the short-acting interferon PEG-Intron has been approved by the Food and Drug Administration FDA for the treatment of Hepatitis C
The goals of this study are
1 To determine how your childs plexiform neurofibroma responds to PEG-Intron when given weekly
2 To determine the side effects of PEG-Intron when given weekly to participants with plexiform neurofibromas
3 To evaluate a new method of measuring changes in the size of tumors called volume analysis This method measures the entire volume of a tumor in three dimensions The standard method of measuring tumors uses only the length andor width of the tumor By studying the different ways of measuring tumors the investigators hope to be able to determine which method is the most accurate and useful
Detailed Description:
PEG-Intron will be given every week through a small needle under the skin in the same way that insulin is given to people with diabetes Subjects will be taught to do this at home As long as the tumor isnt growing and the side effects are tolerable the injections will be given once a week for 2 years
Children will be enrolled on the study into one of three strata patient groups strata 1 includes children who do not have any symptoms associated with their PNF and MRI scans over the past year may or may not show tumor growth strata 2 includes children who have symptoms associated with the PNF but MRI scans over the past year have not shown growth and strata 3 includes children who have shown an increase in the size of the PNF on MRI scans over the past year with or without any symptoms
Children will be enrolled on the study into one of three strata patient groups strata 1 includes children who do not have any symptoms associated with their PNF and MRI scans over the past year may or may not show tumor growth strata 2 includes children who have symptoms associated with the PNF but MRI scans over the past year have not shown growth and strata 3 includes children who have shown an increase in the size of the PNF on MRI scans over the past year with or without any symptoms
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