Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091052
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2004-09-07
Brief Title:
Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors
Sponsor:
Sirius Medicine
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase III Clinical Center Treatment Trial
Status:
COMPLETED
Status Verified Date:
2006-05
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:
RATIONALE Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with sargramostim may kill more tumor cells
PURPOSE This phase III trial is studying the side effects of giving radiation therapy together with sargramostim and to see how well it works in treating patients with advanced solid tumors
PURPOSE This phase III trial is studying the side effects of giving radiation therapy together with sargramostim and to see how well it works in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the safety of contrast-enhanced high-dose radiotherapy administered with sargramostim GM-CSF in patients with advanced solid malignancies
Determine immune response in patients treated with this regimen
Determine tumor response in patients treated with this regimen
OUTLINE Patients are stratified according to prior therapy biopsy or simple surgery vs radical surgery chemotherapy or radiotherapy
Patients receive a contrast agent intratumorally followed by a single fraction of kilovoltage radiotherapy Beginning 24 hours after radiotherapy patients receive sargramostim GM-CSF intratumorally continuously for 1 week and then subcutaneously for 2 weeks Patients with lung tumors receive GM-CSF by inhalation twice daily for 1 week and then every other week for a total of 3 weeks of drug treatment
Treatment may repeat in several weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 47 patients 12 for phase I and 35 for phase II will be accrued for this study
Determine the safety of contrast-enhanced high-dose radiotherapy administered with sargramostim GM-CSF in patients with advanced solid malignancies
Determine immune response in patients treated with this regimen
Determine tumor response in patients treated with this regimen
OUTLINE Patients are stratified according to prior therapy biopsy or simple surgery vs radical surgery chemotherapy or radiotherapy
Patients receive a contrast agent intratumorally followed by a single fraction of kilovoltage radiotherapy Beginning 24 hours after radiotherapy patients receive sargramostim GM-CSF intratumorally continuously for 1 week and then subcutaneously for 2 weeks Patients with lung tumors receive GM-CSF by inhalation twice daily for 1 week and then every other week for a total of 3 weeks of drug treatment
Treatment may repeat in several weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 47 patients 12 for phase I and 35 for phase II will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SIRIUS-01 | None | None | None |
| SIRIUS-1053285 | None | None | None |