Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026221
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2001-11-09
Brief Title:
Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of Bevacizumab and Interferon-Alpha-2b in Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2016-02
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 randomized phase II trial is studying giving bevacizumab together with interferon alpha to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them Interferon alpha may interfere with the growth of the cancer cells and slow the growth of the tumor Combining bevacizumab with interferon alpha may kill more tumor cells
Detailed Description:
OBJECTIVES
I Compare the objective response rate and progression-free survival in patients with metastatic malignant melanoma treated with bevacizumab with or without low- or high-dose interferon alpha
OUTLINE This is a randomized study Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive bevacizumab intravenously IV over 30-90 minutes on day 1 Patients also receive low-dose interferon alpha IFN-alpha subcutaneously SC on days 1-14
ARM II Patients receive bevacizumab as in arm I
ARM III Patients receive bevacizumab as in arm I Patients also receive high-dose IFN-alpha SC on days 1 3 5 8 10 and 12 In all arms treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients undergo restaging at the completion of course 12 Patients with stable disease or a clinical response may continue treatment according to their assigned treatment arm for up to 1 year Patients with stable disease after 1 year of treatment with bevacizumab and IFN-alpha arms I and III may continue to receive bevacizumab alone every 21 days as in arm II in the absence of disease progression
Patients are followed every 3 months for 2 years
I Compare the objective response rate and progression-free survival in patients with metastatic malignant melanoma treated with bevacizumab with or without low- or high-dose interferon alpha
OUTLINE This is a randomized study Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive bevacizumab intravenously IV over 30-90 minutes on day 1 Patients also receive low-dose interferon alpha IFN-alpha subcutaneously SC on days 1-14
ARM II Patients receive bevacizumab as in arm I
ARM III Patients receive bevacizumab as in arm I Patients also receive high-dose IFN-alpha SC on days 1 3 5 8 10 and 12 In all arms treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients undergo restaging at the completion of course 12 Patients with stable disease or a clinical response may continue treatment according to their assigned treatment arm for up to 1 year Patients with stable disease after 1 year of treatment with bevacizumab and IFN-alpha arms I and III may continue to receive bevacizumab alone every 21 days as in arm II in the absence of disease progression
Patients are followed every 3 months for 2 years
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 |
|---|---|---|---|
| P30CA016058 | NIH | CTEP | httpsreporternihgovquickSearchP30CA016058 |
| NCI-2009-00006 | REGISTRY | None | None |
| CDR0000069010 | None | None | None |
| 2001C0185 | None | None | None |
| OSU-01H0185 | None | None | None |
| 0132 | None | None | None |
| NCI-2669 | None | None | None |
| OSU 0132 | OTHER | None | None |
| 2669 | OTHER | None | None |
| N01CM62207 | NIH | None | None |
| R21CA093071 | NIH | None | None |