Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036569
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2002-05-10
Brief Title:
A Phase II Study of Pegylated Interferon Alfa 2b PEG-IntronTrademark in Children With Diffuse Pontine Gliomas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of Pegylated Interferon Alfa-2b Peg-Intron TM in Children With Diffuse Pontine Gliomas
Status:
COMPLETED
Status Verified Date:
2012-01
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:
Diffuse pontine gliomas are tumors on the pons portion of the brainstem Their peak incidence is in children between 5 and 10 years old Their location makes surgical resection impossible Most patients are treated with radiation which typically delays progression of the tumor for a median time of only about 6 months median survival time is less than 1 year The addition of chemotherapy has not improved the outcome
Alpha beta and gamma interferons have been used to treat malignant brain tumors with mixed results Different doses and different methods of administration have been studied Alpha interferon is usually given in high doses 2 or 3 times a week but it has serious side effects at these doses Recent studies have shown that administering chemotherapy more frequently at smaller doses metronomic may have a better effect against the tumor
PEG-IntronTrademark is a form of interferon alpha combined with monomethoxy polyethylene glycol PEG It has a longer half-life than interferon alone is administered once a week and the long half-life reduces the peaks and troughs in blood levels
This study will enroll 32 patients under age 21 The primary goals of the study are to determine if there is a difference in the 2-year survival rate of patients treated with radiation alone and those treated with radiation followed by PEG-IntronTrademark and to define the toxicities of PEG-IntronTrademark in the study doses Secondary goals are to evaluate various magnetic resonance imaging MRI techniques for noninvasive monitoring of changes in the brainstem and to evaluate neuropsychological function
In this study PEG-IntronTrademark will be administered subcutaneously once a week at low doses 03 microgram per kilogram of body weight for a 4-week cycle The cycles will be repeated indefinitely until progression of disease or serious side effects develop For less severe effects the dose will be lowered and the patient may remain in the study For more severe effects the dose will be discontinued Patients in the study may receive supportive medication but may not receive other forms of chemotherapy
Patients or their caregivers will be instructed in how to inject the drug Patients andor caregivers will be asked to maintain a diary documenting the dose site of administration and any side effects The diary will be reviewed at each National Cancer Institute NCI visit Patients will return to NCI before cycles 2 and 3 If there are no significant side effects patients may then return to NCI before every other cycle indefinitely ie before cycles 5 7 9 etc
Patients will undergo the following tests and procedures
Physical examination including neurologic exam monthly
Complete blood count differential and platelet count weekly during cycle 1 and every 2 weeks thereafter if no severe side effects occur
Blood chemistries weekly during cycle 1 and every 2 weeks thereafter if no severe side effects occur
Endocrine function tests before each cycle
Urinalysis before each cycle
MRI of the brain before cycles 1 2 3 5 7 and every other month patients may also have proton magnetic spectroscopic imaging performed at the time of the MRI
Alpha beta and gamma interferons have been used to treat malignant brain tumors with mixed results Different doses and different methods of administration have been studied Alpha interferon is usually given in high doses 2 or 3 times a week but it has serious side effects at these doses Recent studies have shown that administering chemotherapy more frequently at smaller doses metronomic may have a better effect against the tumor
PEG-IntronTrademark is a form of interferon alpha combined with monomethoxy polyethylene glycol PEG It has a longer half-life than interferon alone is administered once a week and the long half-life reduces the peaks and troughs in blood levels
This study will enroll 32 patients under age 21 The primary goals of the study are to determine if there is a difference in the 2-year survival rate of patients treated with radiation alone and those treated with radiation followed by PEG-IntronTrademark and to define the toxicities of PEG-IntronTrademark in the study doses Secondary goals are to evaluate various magnetic resonance imaging MRI techniques for noninvasive monitoring of changes in the brainstem and to evaluate neuropsychological function
In this study PEG-IntronTrademark will be administered subcutaneously once a week at low doses 03 microgram per kilogram of body weight for a 4-week cycle The cycles will be repeated indefinitely until progression of disease or serious side effects develop For less severe effects the dose will be lowered and the patient may remain in the study For more severe effects the dose will be discontinued Patients in the study may receive supportive medication but may not receive other forms of chemotherapy
Patients or their caregivers will be instructed in how to inject the drug Patients andor caregivers will be asked to maintain a diary documenting the dose site of administration and any side effects The diary will be reviewed at each National Cancer Institute NCI visit Patients will return to NCI before cycles 2 and 3 If there are no significant side effects patients may then return to NCI before every other cycle indefinitely ie before cycles 5 7 9 etc
Patients will undergo the following tests and procedures
Physical examination including neurologic exam monthly
Complete blood count differential and platelet count weekly during cycle 1 and every 2 weeks thereafter if no severe side effects occur
Blood chemistries weekly during cycle 1 and every 2 weeks thereafter if no severe side effects occur
Endocrine function tests before each cycle
Urinalysis before each cycle
MRI of the brain before cycles 1 2 3 5 7 and every other month patients may also have proton magnetic spectroscopic imaging performed at the time of the MRI
Detailed Description:
Background
Children with diffuse pontine gliomas have a dismal prognosis Because surgery in this area is difficult radiation therapy has been the mainstay of treatment Although some children may improve clinically after radiation therapy the effect is short-lived and almost all progress within several months Chemotherapy has not had a significant impact on survival Interferon-alpha is a cytokine that has been studied in patients with gliomas and has demonstrated some activity in prior clinical trials
Objectives
To compare the 2-year survival of pediatric patients with diffuse pontine gliomas receiving weekly subcutaneous low-dose pegylated interferon alfa-2b PEG-IntronTM injections after standard radiation therapy versus historical controls who have received radiation therapy alone
To define the toxicities of weekly low-dose pegylated interferon alfa-2b PEG-IntronTrademark in pediatric patients
Eligibility
Age Patients must be less than or equal to 21 years of age
Histological Diagnosis Histologic confirmation is not required for this study Patients must have a diffuse pontine glioma as diagnosed by MRI criteria below
Radiologic Appearance Patients must have a diffuse intrinsic tumor with the epicenter presumed to be in the pons The T-2 weighted sequence must reveal a diffuse signal abnormality involving at least 50 percent of the pons
Prior Therapy The patient must have received adequate radiation therapy Radiation must be completed between 2-10 weeks prior to the start of treatment with Peg-IntronTM
Design
In this study we plan to administer pegylated interferon alfa-2b PEG-IntronTM subcutaneously once a week to pediatric patients with diffuse pontine gliomas who have completed radiation therapy The endpoint of the trial will be 2-year survival compared to historical controls
Children with diffuse pontine gliomas have a dismal prognosis Because surgery in this area is difficult radiation therapy has been the mainstay of treatment Although some children may improve clinically after radiation therapy the effect is short-lived and almost all progress within several months Chemotherapy has not had a significant impact on survival Interferon-alpha is a cytokine that has been studied in patients with gliomas and has demonstrated some activity in prior clinical trials
Objectives
To compare the 2-year survival of pediatric patients with diffuse pontine gliomas receiving weekly subcutaneous low-dose pegylated interferon alfa-2b PEG-IntronTM injections after standard radiation therapy versus historical controls who have received radiation therapy alone
To define the toxicities of weekly low-dose pegylated interferon alfa-2b PEG-IntronTrademark in pediatric patients
Eligibility
Age Patients must be less than or equal to 21 years of age
Histological Diagnosis Histologic confirmation is not required for this study Patients must have a diffuse pontine glioma as diagnosed by MRI criteria below
Radiologic Appearance Patients must have a diffuse intrinsic tumor with the epicenter presumed to be in the pons The T-2 weighted sequence must reveal a diffuse signal abnormality involving at least 50 percent of the pons
Prior Therapy The patient must have received adequate radiation therapy Radiation must be completed between 2-10 weeks prior to the start of treatment with Peg-IntronTM
Design
In this study we plan to administer pegylated interferon alfa-2b PEG-IntronTM subcutaneously once a week to pediatric patients with diffuse pontine gliomas who have completed radiation therapy The endpoint of the trial will be 2-year survival compared to historical controls
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 |
|---|---|---|---|
| 02-C-0193 | None | None | None |