Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001507
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
1999-11-03
Brief Title:
Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Multi-Center Study of PaclitaxelCyclophosphamide and High Dose MelphalanEtoposide With Autologous Progenitor Cell Transplantation for the Treatment of Inflammatory Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-06-20
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 study will evaluate the effectiveness of combination chemotherapy with paclitaxel Taxol and cyclophosphamide Cytoxan followed by high-dose melphalan and etoposide for treating inflammatory breast cancer Patients also receive infusions of their own previously collected progenitor cells primitive cells that can make new cells to replace ones destroyed by chemotherapy
Patients 18 years of age or older with stage IIIB inflammatory breast cancer that has not metastasized spread beyond the breast may be eligible for this study Candidates are screened with a medical history and physical examination blood and urine tests and chest x-ray They have computed tomography CT of the head chest abdomen and pelvis as well as a bone scan to determine the extent of disease and a nuclear medicine scan called MUGA to examine the hearts pumping ability They may receive a rehabilitation medicine evaluation
Participants undergo the following tests and procedures
Central venous line placement Patients have a central venous line plastic tube placed into a major vein in the chest before beginning treatment The line remains in the body throughout treatment and is used to give chemotherapy and other medications and to withdraw blood samples The line is usually placed under local anesthesia in the radiology department or the operating room
Chemotherapy Patients receive two or more cycles of paclitaxel and cyclophosphamide Paclitaxel is given intravenously IV through a vein for 72 hours using a portable pump Cyclophosphamide is given daily for 3 days IV over 1 hour The cycles may be 28 days apart A drug called Mesna is given with this treatment to protect the bladder from irritation from cyclophosphamide Patients who have not previously been treated with doxorubicin Adriamycin may receive a maximum of four cycles of doxorubicin and cyclophosphamide by vein on a single day during each cycle with cycles 21 days apart When all the paclitaxelcyclophosphamide cycles are completed patients receive melphalan and etoposide both drugs IV over 1 to 8 hours for three consecutive days
G-CSF treatment After each paclitaxelcyclophosphamide cycle and after the melphalanetoposide treatment patients are given a drug called G-CSF G-CSF injected under the skin stimulates production of infection-fighting white blood cells
Apheresis This is a procedure to collect progenitor cells for later reinfusion For this procedure blood is collected through a catheter plastic tube placed in an arm vein The blood is circulated through a cell-separating machine where the white cells including the progenitor cells are extracted and the red cells are returned to the patient through another catheter in the other arm Apheresis is done after each of two cycles of paclitaxelcyclophosphamide
Progenitor cell transplant Progenitor cells are reinfused after melphalanetoposide treatment
Glucose infusion A salt solution with chemically modified glucose is infused IV over a period of from 12 to 48 hours with subsequent donation of blood cells for blood and immune system studies Patients have a maximum of two glucose infusions separated by at least 3 months
Tumor biopsy Some patients have a biopsy of their tumor removal of a small piece of tumor tissue for microscopic study before starting chemotherapy
Blood tests Blood is drawn frequently to monitor safety and treatment response and for research purposes
Dental consultation Some patients may have a dental consultation before the progenitor cell transplant
Patients 18 years of age or older with stage IIIB inflammatory breast cancer that has not metastasized spread beyond the breast may be eligible for this study Candidates are screened with a medical history and physical examination blood and urine tests and chest x-ray They have computed tomography CT of the head chest abdomen and pelvis as well as a bone scan to determine the extent of disease and a nuclear medicine scan called MUGA to examine the hearts pumping ability They may receive a rehabilitation medicine evaluation
Participants undergo the following tests and procedures
Central venous line placement Patients have a central venous line plastic tube placed into a major vein in the chest before beginning treatment The line remains in the body throughout treatment and is used to give chemotherapy and other medications and to withdraw blood samples The line is usually placed under local anesthesia in the radiology department or the operating room
Chemotherapy Patients receive two or more cycles of paclitaxel and cyclophosphamide Paclitaxel is given intravenously IV through a vein for 72 hours using a portable pump Cyclophosphamide is given daily for 3 days IV over 1 hour The cycles may be 28 days apart A drug called Mesna is given with this treatment to protect the bladder from irritation from cyclophosphamide Patients who have not previously been treated with doxorubicin Adriamycin may receive a maximum of four cycles of doxorubicin and cyclophosphamide by vein on a single day during each cycle with cycles 21 days apart When all the paclitaxelcyclophosphamide cycles are completed patients receive melphalan and etoposide both drugs IV over 1 to 8 hours for three consecutive days
G-CSF treatment After each paclitaxelcyclophosphamide cycle and after the melphalanetoposide treatment patients are given a drug called G-CSF G-CSF injected under the skin stimulates production of infection-fighting white blood cells
Apheresis This is a procedure to collect progenitor cells for later reinfusion For this procedure blood is collected through a catheter plastic tube placed in an arm vein The blood is circulated through a cell-separating machine where the white cells including the progenitor cells are extracted and the red cells are returned to the patient through another catheter in the other arm Apheresis is done after each of two cycles of paclitaxelcyclophosphamide
Progenitor cell transplant Progenitor cells are reinfused after melphalanetoposide treatment
Glucose infusion A salt solution with chemically modified glucose is infused IV over a period of from 12 to 48 hours with subsequent donation of blood cells for blood and immune system studies Patients have a maximum of two glucose infusions separated by at least 3 months
Tumor biopsy Some patients have a biopsy of their tumor removal of a small piece of tumor tissue for microscopic study before starting chemotherapy
Blood tests Blood is drawn frequently to monitor safety and treatment response and for research purposes
Dental consultation Some patients may have a dental consultation before the progenitor cell transplant
Detailed Description:
BACKGROUND
Efforts to cure high-risk breast cancer have increasingly focused on the application of dose intensive chemotherapy To date the use of dose intensive and high-dose chemotherapy has not significantly changed the survival for the majority of high risk and metastatic patients The optimal schedule and combination of agents to improve the results of high-dose chemotherapy is not known This study will pilot a combination of chemotherapy agents for the treatment of Inflammatory Breast Cancer
OBJECTIVES
To define in a statistically relevant manner the clinical efficacy of this chemotherapy regimen combination in the treatment of Inflammatory Breast Cancer stage IIIB inflammatory
To examine the effects of this high-dose chemotherapy on T-cells T-cell number phenotype cytokine profiles and study the process of post-chemotherapy T-cell regeneration
ELIGIBILITY
Newly diagnosed patient with non metastatic Inflammatory Breast Cancer stage III B
The patients treated in this study will also be eligible for entrance into other protocols of the experimental Transplantation Immunology Branch that are examining strategies of manipulating T-cell regeneration in adults after intensive chemotherapy
DESIGN
Patients will receive multiple cycles of a dose intensive combination of Paclitaxel and Cyclophosphamide both for the mobilization of peripheral blood progenitor cells and with therapeutic intent A second induction regimen will consist of four cycles of the combination of Doxorubicin cyclophosphamide Patients will subsequently receive high-dose Melphalan and Etoposide followed by the infusion of peripheral blood progenitor cells and granulocytes colony-stimulating-factor G-CSF
Efforts to cure high-risk breast cancer have increasingly focused on the application of dose intensive chemotherapy To date the use of dose intensive and high-dose chemotherapy has not significantly changed the survival for the majority of high risk and metastatic patients The optimal schedule and combination of agents to improve the results of high-dose chemotherapy is not known This study will pilot a combination of chemotherapy agents for the treatment of Inflammatory Breast Cancer
OBJECTIVES
To define in a statistically relevant manner the clinical efficacy of this chemotherapy regimen combination in the treatment of Inflammatory Breast Cancer stage IIIB inflammatory
To examine the effects of this high-dose chemotherapy on T-cells T-cell number phenotype cytokine profiles and study the process of post-chemotherapy T-cell regeneration
ELIGIBILITY
Newly diagnosed patient with non metastatic Inflammatory Breast Cancer stage III B
The patients treated in this study will also be eligible for entrance into other protocols of the experimental Transplantation Immunology Branch that are examining strategies of manipulating T-cell regeneration in adults after intensive chemotherapy
DESIGN
Patients will receive multiple cycles of a dose intensive combination of Paclitaxel and Cyclophosphamide both for the mobilization of peripheral blood progenitor cells and with therapeutic intent A second induction regimen will consist of four cycles of the combination of Doxorubicin cyclophosphamide Patients will subsequently receive high-dose Melphalan and Etoposide followed by the infusion of peripheral blood progenitor cells and granulocytes colony-stimulating-factor G-CSF
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 |
|---|---|---|---|
| 96-C-0104 | None | None | None |