Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003042
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
1999-11-01
Brief Title:
Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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 may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer
PURPOSE This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer
Detailed Description:
OBJECTIVES
Determine the effectiveness of neoadjuvant dose intensive sequential chemotherapy followed by surgical resection adjuvant therapy and tandem high dose chemotherapy and stem cell rescue in patients with inflammatory stage IIIB breast cancer
Determine the clinical and pathological remission rate complete partial and overall following neoadjuvant dose dependent sequential chemotherapy in patients with inflammatory stage IIIB breast cancer
Determine the relapse and survival rate of these patients with the above therapy
Determine the potential correlations between inflammatory features and hereditary background
OUTLINE Patients are stratified according to those who have had no more than 1 cycle of neoadjuvant chemotherapy stratum 1 and those who have had more than 1 cycle of neoadjuvant chemotherapy andor modified radical mastectomy stratum 2
Patients in stratum 1 receive doxorubicin IV over 96 hours on days 1-4 15-19 and 29-32 Paclitaxel is infused over 96 hours on days 43-47 and 57-60 Filgrastim G-CSF is administered on days 5-10 20-25 33-38 48-55 and 61-68 and beyond if the granulocyte count is less than 1000mm3 A modified radical mastectomy is performed between days 70 and 80 All stratum 1 and stratum 2 patients then receive paclitaxel IV for 96 hours on days 100-104 and cyclophosphamide IV on day 121 Filgrastim is administered at one dose on days 105-110 and days 122-127 and at a higher dose on days 110-116 and days 128-135 Stem cells are harvested from the patient on days 113-116 and days 132-135
High-dose chemotherapy is then administered to all patients in the study Course 1 starts with doxorubicin IV on days -7 to -3 Paclitaxel IV is administered for 24 hours on day -2 Filgrastim is administered by IV on day -1 and continued until the granulocyte count is greater than 1000mm3 for 3 days Peripheral stem cells are reinfused on day 0 Course 2 starts 4-6 weeks after the start of course 1 with melphalan and cisplatin being infused on day -11 Filgrastim is administered IV on days -10 to -6 Melphalan and cisplatin are administered again on day -4 Stem cells are infused on day -3 and on day 0 Filgrastim is then administered until the granulocyte count is at least 1000mm3 for 3 days
Radiation therapy is started 4-7 weeks after the beginning of course 2 Tamoxifen is started within 2 weeks of discharge following course 2 in patients with hormone receptor positive tumors
Patients are followed every 3 months for two years and then annually for the next three years
PROJECTED ACCRUAL Approximately 60 patients will be accrued at a rate of about 15 per year
Determine the effectiveness of neoadjuvant dose intensive sequential chemotherapy followed by surgical resection adjuvant therapy and tandem high dose chemotherapy and stem cell rescue in patients with inflammatory stage IIIB breast cancer
Determine the clinical and pathological remission rate complete partial and overall following neoadjuvant dose dependent sequential chemotherapy in patients with inflammatory stage IIIB breast cancer
Determine the relapse and survival rate of these patients with the above therapy
Determine the potential correlations between inflammatory features and hereditary background
OUTLINE Patients are stratified according to those who have had no more than 1 cycle of neoadjuvant chemotherapy stratum 1 and those who have had more than 1 cycle of neoadjuvant chemotherapy andor modified radical mastectomy stratum 2
Patients in stratum 1 receive doxorubicin IV over 96 hours on days 1-4 15-19 and 29-32 Paclitaxel is infused over 96 hours on days 43-47 and 57-60 Filgrastim G-CSF is administered on days 5-10 20-25 33-38 48-55 and 61-68 and beyond if the granulocyte count is less than 1000mm3 A modified radical mastectomy is performed between days 70 and 80 All stratum 1 and stratum 2 patients then receive paclitaxel IV for 96 hours on days 100-104 and cyclophosphamide IV on day 121 Filgrastim is administered at one dose on days 105-110 and days 122-127 and at a higher dose on days 110-116 and days 128-135 Stem cells are harvested from the patient on days 113-116 and days 132-135
High-dose chemotherapy is then administered to all patients in the study Course 1 starts with doxorubicin IV on days -7 to -3 Paclitaxel IV is administered for 24 hours on day -2 Filgrastim is administered by IV on day -1 and continued until the granulocyte count is greater than 1000mm3 for 3 days Peripheral stem cells are reinfused on day 0 Course 2 starts 4-6 weeks after the start of course 1 with melphalan and cisplatin being infused on day -11 Filgrastim is administered IV on days -10 to -6 Melphalan and cisplatin are administered again on day -4 Stem cells are infused on day -3 and on day 0 Filgrastim is then administered until the granulocyte count is at least 1000mm3 for 3 days
Radiation therapy is started 4-7 weeks after the beginning of course 2 Tamoxifen is started within 2 weeks of discharge following course 2 in patients with hormone receptor positive tumors
Patients are followed every 3 months for two years and then annually for the next three years
PROJECTED ACCRUAL Approximately 60 patients will be accrued at a rate of about 15 per year
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 |
|---|---|---|---|
| CDR0000065672 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-96139 | None | None | None |
| NCI-G97-1288 | None | None | None |