Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466960
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2007-04-25
Brief Title:
Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor GM-CSF With Weekly Protein Bound Paclitaxel Abraxane as Chemoimmunotherapy for Platinum-RefractoryResistant Epithelial Ovarian Primary Peritoneal and Fallopian Tube Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
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 GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing and may also increase the number of immune cells found in bone marrow or peripheral blood and help the immune system recover from the side effects of chemotherapy Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for ovarian cancer fallopian tube cancer and primary peritoneal cancer
PURPOSE This phase II trial is studying how well giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian cancer fallopian tube cancer or primary peritoneal cancer that did not respond to previous chemotherapy
PURPOSE This phase II trial is studying how well giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian cancer fallopian tube cancer or primary peritoneal cancer that did not respond to previous chemotherapy
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether chronic GM-CSF administration during and after cytotoxic chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer remission than experienced in the most recent platinum-containing regimen
SECONDARY OBJECTIVES
I To determine the extent to which chronic GM-CSF administration can increase the number of activated monocytes in patients with advanced stage epithelial ovarian cancer
II To determine the extent to which chronic GM-CSF administration can increase the number and activation state of peripheral circulating antigen presenting cells such as dendritic cells and activated monocytes in patients with advanced epithelial ovarian cancer
III To determine the extent to which chronic GM-CSF administration can increase the number and functional status of T cells that recognize tumor specific antigens in patients with advanced stage epithelial ovarian cancer
IV To determine the extent to which chronic GM-CSF administration can increase the number and functional status of antigen specific T cells that recognize foreign pathogens in patients with advanced stage epithelial ovarian cancer
OUTLINE
INDUCTION THERAPY Patients receive GM-CSF subcutaneously SC once daily on days 16-26 Patients also receive paclitaxel albumin-stabilized nanoparticle formulation intravenously IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity
MAINTENANCE THERAPY Beginning 14 days after last GM-CSF injection patients receive GM-CSF SC once daily on days 1-15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up monthly for 6 months and then every 3 months thereafter
I To determine whether chronic GM-CSF administration during and after cytotoxic chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer remission than experienced in the most recent platinum-containing regimen
SECONDARY OBJECTIVES
I To determine the extent to which chronic GM-CSF administration can increase the number of activated monocytes in patients with advanced stage epithelial ovarian cancer
II To determine the extent to which chronic GM-CSF administration can increase the number and activation state of peripheral circulating antigen presenting cells such as dendritic cells and activated monocytes in patients with advanced epithelial ovarian cancer
III To determine the extent to which chronic GM-CSF administration can increase the number and functional status of T cells that recognize tumor specific antigens in patients with advanced stage epithelial ovarian cancer
IV To determine the extent to which chronic GM-CSF administration can increase the number and functional status of antigen specific T cells that recognize foreign pathogens in patients with advanced stage epithelial ovarian cancer
OUTLINE
INDUCTION THERAPY Patients receive GM-CSF subcutaneously SC once daily on days 16-26 Patients also receive paclitaxel albumin-stabilized nanoparticle formulation intravenously IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity
MAINTENANCE THERAPY Beginning 14 days after last GM-CSF injection patients receive GM-CSF SC once daily on days 1-15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up monthly for 6 months and then every 3 months thereafter
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-2010-00556 | REGISTRY | CTRP Clinical Trial Reporting Program | None |