Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445523
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2007-03-08
Brief Title:
Safety Study of TroVax Alone vs TroVax Plus Interferon Alpha in Patients With Renal Cancer
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
A Phase II Trial to Assess the Activity of TroVax Alone vs TroVax Plus Interferon Alfa IFN-α on Patients With Advanced or Metastatic Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
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:
Patients with metastatic renal cell cancer will be enrolled to receive either Trovax alone or Trovax plus Interferon Alfa The study will try to determine whether the use of Trovax will delay tumor progression
Detailed Description:
Patients with metastatic renal cell cancer will be enrolled in the study if all inclusionexclusion criteria are met Once the patient is enrolled and baseline tests have been completed the patient will start treatment
Trovax alone arm
Trovax will be given as an intramuscular injection every two weeks for the first two months then once a month for the next 2 months and then once every 2 months for up to a year
Trovax plus IFN-α
Trovax schedule will be the same as the Trovax alone arm IFN will be given on the first third and fifth day of the week for a total of twelve weeks
At every office visit vital signs will be taken Every eight weeks a medical history physical exam performance status evaluation chest x-ray or CT scan abdomenpelvis CT scan or MRI will be done A blood sample about 8-10 tablespoons will be taken to test the immunological response to TroVax on the same days that the patient receives TroVax injections
Trovax alone arm
Trovax will be given as an intramuscular injection every two weeks for the first two months then once a month for the next 2 months and then once every 2 months for up to a year
Trovax plus IFN-α
Trovax schedule will be the same as the Trovax alone arm IFN will be given on the first third and fifth day of the week for a total of twelve weeks
At every office visit vital signs will be taken Every eight weeks a medical history physical exam performance status evaluation chest x-ray or CT scan abdomenpelvis CT scan or MRI will be done A blood sample about 8-10 tablespoons will be taken to test the immunological response to TroVax on the same days that the patient receives TroVax injections
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 |
|---|---|---|---|
| TV200206 | None | None | None |