Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090870
Status:
TERMINATED
Last Update Posted:
2018-07-12
First Post:
2004-09-07
Brief Title:
PEG-Interferon Alfa-2b Sargramostim and Thalidomide in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Phase II Study Of Peg-Intron GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pharmaceutical collaborator pulled funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE PEG-interferon alfa-2b may interfere with the growth of tumor cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells
PURPOSE This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer
PURPOSE This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response to PEG-interferon alfa-2b sargramostim GM-CSF and thalidomide in patients with metastatic renal cell carcinoma
Secondary
Determine duration of response in patients treated with this regimen
Determine the tolerance to and toxicity of this regimen in these patients
Determine the median and progression-free survival of patients treated with this regimen
OUTLINE Patients receive PEG-interferon alfa-2b subcutaneously SC on days 1 and 8 sargramostim GM-CSF SC on days 1-10 and oral thalidomide once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Primary
Determine the response to PEG-interferon alfa-2b sargramostim GM-CSF and thalidomide in patients with metastatic renal cell carcinoma
Secondary
Determine duration of response in patients treated with this regimen
Determine the tolerance to and toxicity of this regimen in these patients
Determine the median and progression-free survival of patients treated with this regimen
OUTLINE Patients receive PEG-interferon alfa-2b subcutaneously SC on days 1 and 8 sargramostim GM-CSF SC on days 1-10 and oral thalidomide once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
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 |
|---|---|---|---|
| MUSC-HR-10423 | None | None | None |
| MUSC-100614 | None | None | None |
| CELGENE-MUSC-100614 | None | None | None |