Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397982
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2006-11-09
Brief Title:
Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of CCI-779 in Combination With Bevacizumab in Stage III or IV Melanoma
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Mel47
Brief Summary:
This phase II trial is studying how well giving temsirolimus together with bevacizumab works in treating patients with stage III or stage IV malignant melanoma Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of malignant melanoma by blocking blood flow to the tumor Giving temsirolimus together with bevacizumab may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective tumor response rate complete response and partial response in patients with stage III or IV melanoma treated with temsirolimus and bevacizumab
SECONDARY OBJECTIVES
I Describe the adverse event profile of this regimen in these patients II Determine the efficacy of this regimen in terms of progression-free survival in these patients
III Compare pre- vs post-treatment measurements of biomarkers and vascular systemimmune system parameters in patients treated with this regimen
IV Correlate tumor and blood biomarkers with clinical response in these patients
OUTLINE This is a multicenter study
Patients receive temsirolimus intravenously IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8 Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity Patients undergo tumor resection on day 9 of course 2Blood samples are collected during courses 1 and 2 Samples are examined by flow cytometry to evaluate peripheral blood mononuclear cells for molecular effects of study agents Patients also undergo normal and tumor tissue biopsy by core needle biopsy incisional biopsy or surgical resection during courses 1 and 2 Samples are examined by immunohistochemistry western blotting protein array technology gene expression analyses DNA mutation analyses and genomic analyses for pre-and post-treatment measurements of target molecules epidermal growth factor receptor B-Raf MEK MAPK downstream pathway components PI-3 kinase AKT mTOR markers of angiogenesis proliferation and apoptosis markers that may modulate cell signaling or the response to investigational agents and vascular and immune system parameters
After completion of study treatment patients are followed at 1 month every 3 months for up to 2 years and then periodically for up to 5 years
I Determine the objective tumor response rate complete response and partial response in patients with stage III or IV melanoma treated with temsirolimus and bevacizumab
SECONDARY OBJECTIVES
I Describe the adverse event profile of this regimen in these patients II Determine the efficacy of this regimen in terms of progression-free survival in these patients
III Compare pre- vs post-treatment measurements of biomarkers and vascular systemimmune system parameters in patients treated with this regimen
IV Correlate tumor and blood biomarkers with clinical response in these patients
OUTLINE This is a multicenter study
Patients receive temsirolimus intravenously IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8 Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity Patients undergo tumor resection on day 9 of course 2Blood samples are collected during courses 1 and 2 Samples are examined by flow cytometry to evaluate peripheral blood mononuclear cells for molecular effects of study agents Patients also undergo normal and tumor tissue biopsy by core needle biopsy incisional biopsy or surgical resection during courses 1 and 2 Samples are examined by immunohistochemistry western blotting protein array technology gene expression analyses DNA mutation analyses and genomic analyses for pre-and post-treatment measurements of target molecules epidermal growth factor receptor B-Raf MEK MAPK downstream pathway components PI-3 kinase AKT mTOR markers of angiogenesis proliferation and apoptosis markers that may modulate cell signaling or the response to investigational agents and vascular and immune system parameters
After completion of study treatment patients are followed at 1 month every 3 months for up to 2 years and then periodically for up to 5 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 |
|---|---|---|---|
| NCI-2009-00133 | REGISTRY | None | None |
| NCI-7190 | None | None | None |
| CDR0000512836 | None | None | None |
| UVACC-MEL-47 | None | None | None |
| MEL47 | OTHER | None | None |
| 7190 | OTHER | None | None |
| P30CA044579 | NIH | None | None |
| R21CA128367 | NIH | CTEP | httpsreporternihgovquickSearchR21CA128367 |