Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008203
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2001-01-06
Brief Title:
Comparison of Biological Therapies Following Combination Chemotherapy and Bone Marrow or Peripheral Stem Cell Transplantation in Women With Stage II or Stage III Breast Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
High-Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support And One Of Two Regimens Aimed At Modifying Immune Reconstitution In Women With High Risk Stage 2 And Stage 3 Breast Cancer
Status:
COMPLETED
Status Verified Date:
2003-05
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Biological therapy may interfere with the growth of the cancer cells It is not yet known which post-transplant biological therapy regimen is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cyclosporine and interferon gamma to that of interleukin-2 following combination chemotherapy and bone marrow or peripheral stem cell transplantation in women who have stage II or stage III breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cyclosporine and interferon gamma to that of interleukin-2 following combination chemotherapy and bone marrow or peripheral stem cell transplantation in women who have stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Determine the response disease-free survival DFS and overall survival of women with high-risk stage II or III breast cancer treated with high-dose cyclophosphamide thiotepa and carboplatin with autologous marrow andor peripheral blood stem cell transplantation
Determine the safety of immunomodulation consisting of cyclosporine and interferon gamma versus low-dose interleukin-2 in this patient population
Determine parameters associated with immune activation and autologous graft-versus-host disease
Determine which immunomodulation regimen is more efficacious with respect to DSF
OUTLINE This is a randomized study Patients are stratified according to stage II vs III age lymph node status and inflammatory histology Patients are randomized to one of two immunomodulation arms
Autologous harvest of at least 1 million CD34 cells kg or 400 million mononuclear cellskg must be achieved
All patients receive cyclophosphamide IV continuously and thiotepa IV continuously over 96 hours on days -6 through -3 and carboplatin IV over 5 hours daily on days -6 through -3 Patients undergo autologous bone marrow andor peripheral blood stem cell transfusion on day 0
Arm I Patients receive cyclosporine IV over 4 hours twice a day beginning on day 0 and continuing until discharge from the hospital and interferon gamma subcutaneously SC every 2 days on days 7-28
Arm II Patients receive interleukin-2 SC daily for 28 days following recovery of blood counts
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then annually for 5 years
PROJECTED ACCRUAL A total of 70 patients 30 with stage II disease and 40 with stage III disease will be accrued over 2 years
Determine the response disease-free survival DFS and overall survival of women with high-risk stage II or III breast cancer treated with high-dose cyclophosphamide thiotepa and carboplatin with autologous marrow andor peripheral blood stem cell transplantation
Determine the safety of immunomodulation consisting of cyclosporine and interferon gamma versus low-dose interleukin-2 in this patient population
Determine parameters associated with immune activation and autologous graft-versus-host disease
Determine which immunomodulation regimen is more efficacious with respect to DSF
OUTLINE This is a randomized study Patients are stratified according to stage II vs III age lymph node status and inflammatory histology Patients are randomized to one of two immunomodulation arms
Autologous harvest of at least 1 million CD34 cells kg or 400 million mononuclear cellskg must be achieved
All patients receive cyclophosphamide IV continuously and thiotepa IV continuously over 96 hours on days -6 through -3 and carboplatin IV over 5 hours daily on days -6 through -3 Patients undergo autologous bone marrow andor peripheral blood stem cell transfusion on day 0
Arm I Patients receive cyclosporine IV over 4 hours twice a day beginning on day 0 and continuing until discharge from the hospital and interferon gamma subcutaneously SC every 2 days on days 7-28
Arm II Patients receive interleukin-2 SC daily for 28 days following recovery of blood counts
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then annually for 5 years
PROJECTED ACCRUAL A total of 70 patients 30 with stage II disease and 40 with stage III disease will be accrued over 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 |
|---|---|---|---|
| NCI-G00-1890 | None | None | None |
| CPMC-IRB-7608 | None | None | None |
| CPMC-CAMP-014 | None | None | None |