Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022230
Status:
WITHDRAWN
Last Update Posted:
2015-05-05
First Post:
2001-08-10
Brief Title:
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer
Sponsor:
Roger Williams Medical Center
Organization:
Roger Williams Medical Center
Study Overview
Official Title:
Combination of Chemotherapy With Taxol Adriamycin and Cytoxan TAC Multiple Infusions of Activated T Cells ATC Interleukin-2 IL-2 and GM-CSF for High Risk Breast Cancer With and Without Her2Neu Overexpression Phase III
Status:
WITHDRAWN
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left Institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing Combining chemotherapy with biological therapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects of giving chemotherapy together with biological therapy and to see how well they work in treating patients with stage II or stage III breast cancer
PURPOSE This phase III trial is studying the side effects of giving chemotherapy together with biological therapy and to see how well they work in treating patients with stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Determine the toxic effects of sequential paclitaxel or other taxane doxorubicin and cyclophosphamide followed by immunotherapy with activated T cells interleukin-2 and sargramostim GM-CSF in patients with high-risk stage II or III breast cancer
Determine the disease-free survival and overall survival of patients treated with this regimen
Determine the immune function of patients treated with this regimen
OUTLINE Patients are stratified according to number of positive lymph nodes less than 4 nodes vs 4-9 nodes vs 10 or more nodes type of taxane chemotherapy during study paclitaxel vs other taxane and prior treatment with 2 of 3 study chemotherapy agents yes vs no
Patients receive doxorubicin IV on day 1 and filgrastim G-CSF on days 3-10 of 3 consecutive 14-day courses Patients then receive paclitaxel or another taxane IV on day 1 and G-CSF on days 3-10 of 3 consecutive 14-day courses Patients then receive cyclophosphamide IV on day 1 and G-CSF on days 3-10 of 3 consecutive 14-day courses Patients who enroll after previously receiving 2 of these 3 chemotherapy drugs may receive the third Treatment continues in the absence of disease progression or unacceptable toxicity
After recovery from chemotherapy patients undergo peripheral blood mononuclear cell PBMC collection The PBMC are treated ex vivo with monoclonal antibody OKT3 to form activated T cells ATC The ATC are expanded for up to 14 days in interleukin-2 IL-2
At 3-4 weeks after PBMC collection patients receive ATC IV over 15-30 minutes weekly for 8 weeks Patients also receive IL-2 subcutaneously SC daily and sargramostim GM-CSF SC twice weekly beginning 3 days before the first ATC infusion and continuing until 7 days after completion of ATC therapy
Patients are followed every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40-60 patients will be accrued for this study within 4-5 years
Determine the toxic effects of sequential paclitaxel or other taxane doxorubicin and cyclophosphamide followed by immunotherapy with activated T cells interleukin-2 and sargramostim GM-CSF in patients with high-risk stage II or III breast cancer
Determine the disease-free survival and overall survival of patients treated with this regimen
Determine the immune function of patients treated with this regimen
OUTLINE Patients are stratified according to number of positive lymph nodes less than 4 nodes vs 4-9 nodes vs 10 or more nodes type of taxane chemotherapy during study paclitaxel vs other taxane and prior treatment with 2 of 3 study chemotherapy agents yes vs no
Patients receive doxorubicin IV on day 1 and filgrastim G-CSF on days 3-10 of 3 consecutive 14-day courses Patients then receive paclitaxel or another taxane IV on day 1 and G-CSF on days 3-10 of 3 consecutive 14-day courses Patients then receive cyclophosphamide IV on day 1 and G-CSF on days 3-10 of 3 consecutive 14-day courses Patients who enroll after previously receiving 2 of these 3 chemotherapy drugs may receive the third Treatment continues in the absence of disease progression or unacceptable toxicity
After recovery from chemotherapy patients undergo peripheral blood mononuclear cell PBMC collection The PBMC are treated ex vivo with monoclonal antibody OKT3 to form activated T cells ATC The ATC are expanded for up to 14 days in interleukin-2 IL-2
At 3-4 weeks after PBMC collection patients receive ATC IV over 15-30 minutes weekly for 8 weeks Patients also receive IL-2 subcutaneously SC daily and sargramostim GM-CSF SC twice weekly beginning 3 days before the first ATC infusion and continuing until 7 days after completion of ATC therapy
Patients are followed every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40-60 patients will be accrued for this study within 4-5 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 |
|---|---|---|---|
| RWMC-0633846 | None | None | None |