Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504140
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2007-07-17
Brief Title:
Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma
Status:
COMPLETED
Status Verified Date:
2012-08
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:
Primary Objectives
1 To determine the efficacy of combining Interferon Alpha IFN with etoposide for the treatment of relapsed osteosarcoma
2 To determine if IFN alters the plasma pharmacokinetics of etoposide
3 To determine the toxicities of IFN and etoposide when administered together
4 To determine IFN blood levels following combination therapy
1 To determine the efficacy of combining Interferon Alpha IFN with etoposide for the treatment of relapsed osteosarcoma
2 To determine if IFN alters the plasma pharmacokinetics of etoposide
3 To determine the toxicities of IFN and etoposide when administered together
4 To determine IFN blood levels following combination therapy
Detailed Description:
Interferon Alpha IFN- will be given as a shot under the skin One hour later VP-16 will be infused through a catheter tube placed in a vein over 3 hours The drugs will be given daily for 5 days The treatment will be repeated every 3 - 4 weeks for up to 24 - 32 weeks 8 courses The catheter will remain in place throughout treatment
Patients who are candidates for surgery will first receive two courses of treatment If the tumor gets worse or if severe side effects occur treatment will be stopped and the tumor will be removed right away If the tumor responds well begins to shrink or does not get worse and severe side effects do not occur the patient will receive six more courses of treatment after surgery
Patients who are not candidates for surgery will receive two initial courses of treatment If the tumor responds well and severe side effects do not occur the patient will receive six more courses of treatment
The treatment will be given in the outpatient department Before treatment begins the patient will have a health examination Blood tests a urine test and heart tests will be given X-rays computed tomography CT scans and a bone scan will be done The location and size of all lesions will be recorded
During treatment patients will have a blood test every week Before each course a health examination a urine test and chest x-ray will be given and the size of all measurable cancer will be recorded After the second course the CT and bone scans will be repeated All the tests will be repeated at the end of the study
About 37 patients will be treated on the study at M D Anderson
THIS IS AN INVESTIGATIONAL STUDY IFN- and VP-16 are approved by the US Food and Drug Administration for treating some types of cancer Their use together against osteosarcoma is investigational
Patients who are candidates for surgery will first receive two courses of treatment If the tumor gets worse or if severe side effects occur treatment will be stopped and the tumor will be removed right away If the tumor responds well begins to shrink or does not get worse and severe side effects do not occur the patient will receive six more courses of treatment after surgery
Patients who are not candidates for surgery will receive two initial courses of treatment If the tumor responds well and severe side effects do not occur the patient will receive six more courses of treatment
The treatment will be given in the outpatient department Before treatment begins the patient will have a health examination Blood tests a urine test and heart tests will be given X-rays computed tomography CT scans and a bone scan will be done The location and size of all lesions will be recorded
During treatment patients will have a blood test every week Before each course a health examination a urine test and chest x-ray will be given and the size of all measurable cancer will be recorded After the second course the CT and bone scans will be repeated All the tests will be repeated at the end of the study
About 37 patients will be treated on the study at M D Anderson
THIS IS AN INVESTIGATIONAL STUDY IFN- and VP-16 are approved by the US Food and Drug Administration for treating some types of cancer Their use together against osteosarcoma is investigational
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