Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047879
Status:
COMPLETED
Last Update Posted:
2011-10-26
First Post:
2006-06-19
Brief Title:
Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of Peg-Interferon Alpha-2B Peg-IntronTM and Thalidomide in Adults With Recurrent High-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2011-09
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 will examine the safety and effectiveness of peginterferon alpha-2b PEG-Intron alone and together with thalidomide in patients with gliomas a type of brain tumor Gliomas are nourished by blood delivered through blood vessels whose formation is stimulated by substances produced by the tumor itself Stopping the growth of new vessels can slow or prevent tumor growth The Food and Drug Administration has approved various interferons for treating several diseases including melanoma and some leukemias These drugs block new vessel growth in patients with recurrent tumors but in high doses they produce serious side effects Therefore this study will use a low dose of PEG-Intron given weekly instead of high doses given several times a week Thalidomide currently approved to treat leprosy also blocks development of new blood vessel formation In a recent study of thalidomide given to 36 patients with gliomas 4 patients had tumor shrinkage 12 had stable disease for at least 2 months and at least 3 had responses to treatment lasting 6 to 14 months
Patients 18 years of age and older with a primary glioma whose tumor has recurred or is growing following standard treatment and does not respond to radiation therapy may be eligible for this study Candidates will be screened with a physical examination blood and urine tests including a pregnancy test for women of childbearing potential and magnetic resonance imaging MRI or computed tomography CT of the head
Patients will continue treatment cycles as long as the drug is tolerated without serious side effects and the tumor is not growing While on the study patients will undergo various tests and procedures as follows
Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to assess tumor status MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissues During the scan the patient lies on a table in a narrow cylinder containing a magnetic field He or she can speak with a staff member through an intercom system at all times during the procedure
Patients 18 years of age and older with a primary glioma whose tumor has recurred or is growing following standard treatment and does not respond to radiation therapy may be eligible for this study Candidates will be screened with a physical examination blood and urine tests including a pregnancy test for women of childbearing potential and magnetic resonance imaging MRI or computed tomography CT of the head
Patients will continue treatment cycles as long as the drug is tolerated without serious side effects and the tumor is not growing While on the study patients will undergo various tests and procedures as follows
Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to assess tumor status MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissues During the scan the patient lies on a table in a narrow cylinder containing a magnetic field He or she can speak with a staff member through an intercom system at all times during the procedure
Detailed Description:
Background
There is a growing belief that angiogenesis inhibition represents a potentially promising novel therapeutic approach to highly vascular solid tumors like malignant gliomas Thalidomide and Peg-Intron IFN - Interferon are attractive drugs to use in combination to test the hypothesis of combination anti-angiogenesis therapy inhibition given their proven activity as single agents in patients with malignant gliomas and their spectrum of largely non-overlapping toxicities
Given recent preclinical data describing more potent antiangiogenic and anti-tumor effects of low dose continuous IFN administration we are interested in evaluating the use of pegylated IFN in combination with thalidomide Thus we are proposing a phase II trial of pegylated IFN with thalidomide in patients with recurrent gliomas
Objectives
To obtain preliminary evidence of anti-tumor efficacy of PEG-Intron in combination with thalidomide in patients with recurrent high grade gliomas as assessed by prolongation of progression-free survival compared to historical controls
A secondary endpoint in this trial is to determine the response rate associated with the combination therapy in each of the two strata and to evaluate and document all toxicities from PEG-Intron in combination with thalidomide at the doses prescribed in this protocol in this patient population
Eligibility
Patients with histologically proven supratentorial malignant primary gliomas will be eligible for this protocol These include glioblastoma multiforme GBM anaplastic astrocytoma AA anaplastic oligodendroglioma AO anaplastic mixed oligoastrocytoma AMO or malignant astrocytoma NOS not otherwise specified
Patients must not have received prior therapy with Peg-Intron or Thalidomide
Design
Patients will be treated with weekly PEG-Intron plus daily oral thalidomide All patients will be treated for 6 weeks following which patients will have a repeat MRI scan to assess disease response
There is a growing belief that angiogenesis inhibition represents a potentially promising novel therapeutic approach to highly vascular solid tumors like malignant gliomas Thalidomide and Peg-Intron IFN - Interferon are attractive drugs to use in combination to test the hypothesis of combination anti-angiogenesis therapy inhibition given their proven activity as single agents in patients with malignant gliomas and their spectrum of largely non-overlapping toxicities
Given recent preclinical data describing more potent antiangiogenic and anti-tumor effects of low dose continuous IFN administration we are interested in evaluating the use of pegylated IFN in combination with thalidomide Thus we are proposing a phase II trial of pegylated IFN with thalidomide in patients with recurrent gliomas
Objectives
To obtain preliminary evidence of anti-tumor efficacy of PEG-Intron in combination with thalidomide in patients with recurrent high grade gliomas as assessed by prolongation of progression-free survival compared to historical controls
A secondary endpoint in this trial is to determine the response rate associated with the combination therapy in each of the two strata and to evaluate and document all toxicities from PEG-Intron in combination with thalidomide at the doses prescribed in this protocol in this patient population
Eligibility
Patients with histologically proven supratentorial malignant primary gliomas will be eligible for this protocol These include glioblastoma multiforme GBM anaplastic astrocytoma AA anaplastic oligodendroglioma AO anaplastic mixed oligoastrocytoma AMO or malignant astrocytoma NOS not otherwise specified
Patients must not have received prior therapy with Peg-Intron or Thalidomide
Design
Patients will be treated with weekly PEG-Intron plus daily oral thalidomide All patients will be treated for 6 weeks following which patients will have a repeat MRI scan to assess disease response
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 |
|---|---|---|---|
| 030002 | OTHER | Clinical Center CC National Institutes of Health NIH | None |
| 03-C-0002 | OTHER | None | None |