Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001498
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Cancer
Status:
COMPLETED
Status Verified Date:
2000-01
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:
Stage III patients may begin therapy prior to or following surgery Patients with undrainable significant third space fluid collection eg pleural effusions ascites are entered directly on Consolidation
Patients receive induction chemotherapy with methotrexate and fluorouracil every 2 weeks for 4 courses
Patients then receive two 3-week courses of consolidation therapy with cyclophosphamide followed by daily granulocyte colony-stimulating factor until completion of leukapheresis Patients next receive myeloablative doses of thiotepa followed by stem cell rescue and granulocyte colony-stimulating factor
After hematopoietic reconstitution patients receive 24-hour infusions of paclitaxel every 3 weeks for 4 doses followed by doxorubicin or vinblastine every 3 weeks for 4 doses Patients are then evaluated for additional therapy surgery radiotherapy or hormonal therapy as appropriate
Patients are followed every 3 months for 1 year then every 6 months
Patients receive induction chemotherapy with methotrexate and fluorouracil every 2 weeks for 4 courses
Patients then receive two 3-week courses of consolidation therapy with cyclophosphamide followed by daily granulocyte colony-stimulating factor until completion of leukapheresis Patients next receive myeloablative doses of thiotepa followed by stem cell rescue and granulocyte colony-stimulating factor
After hematopoietic reconstitution patients receive 24-hour infusions of paclitaxel every 3 weeks for 4 doses followed by doxorubicin or vinblastine every 3 weeks for 4 doses Patients are then evaluated for additional therapy surgery radiotherapy or hormonal therapy as appropriate
Patients are followed every 3 months for 1 year then every 6 months
Detailed Description:
This pilot trial will examine the feasibility of administering induction high-dose therapy with antimetabolites followed with consolidation using high-dose single alkylating agent therapy and finally intensification therapy with sequential cycles of very high doses of the natural products paclitaxel followed by doxorubicin to patients with metastatic breast cancer stage IV and to patients with lesser stage disease at high risk for relapse patients with four or more positive nodes stage II locally advanced breast cancer stage III and patients with locally or regionally recurrent breast cancer
Patients will receive induction therapy with antimetabolite agents methotrexate leucovorin and 5-fluorouracil for four cycles Patients will then receive consolidation therapy with three cycles of high-dose alkylating agents First patients will receive one cycle of high-dose cyclophosphamide administered with growth factor support PBPCs will be harvested during the recovery phase of the cyclophosphamide cycle
The next cycle will consist of high-dose single agent thiotepa Hematopoietic stem cells mobilized and collected during the previous cyclophosphamide cycles will be reinfused following treatment with thiotepa to augment recovery of bone marrow function After recovery intensification with natural product chemotherapy will be administered consisting of four cycles of paclitaxel given as a 24-hour infusion followed by four cycles of single agent doxorubicin
This protocol combines several highly active chemotherapeutic agents in an attempt to improve upon response rates achieved with current combinations For high-risk stage II and III patients this chemotherapy regimen without genetic manipulation of PBPCs will serve as a chemotherapy backbone onto which a companion immunotherapy protocol will be offered An identical chemotherapy regimen will be offered to stage four patients as a backbone for a trial of retroviral transduction of the MDR1 and NeoR genes into harvested PBPCs
Patients will receive induction therapy with antimetabolite agents methotrexate leucovorin and 5-fluorouracil for four cycles Patients will then receive consolidation therapy with three cycles of high-dose alkylating agents First patients will receive one cycle of high-dose cyclophosphamide administered with growth factor support PBPCs will be harvested during the recovery phase of the cyclophosphamide cycle
The next cycle will consist of high-dose single agent thiotepa Hematopoietic stem cells mobilized and collected during the previous cyclophosphamide cycles will be reinfused following treatment with thiotepa to augment recovery of bone marrow function After recovery intensification with natural product chemotherapy will be administered consisting of four cycles of paclitaxel given as a 24-hour infusion followed by four cycles of single agent doxorubicin
This protocol combines several highly active chemotherapeutic agents in an attempt to improve upon response rates achieved with current combinations For high-risk stage II and III patients this chemotherapy regimen without genetic manipulation of PBPCs will serve as a chemotherapy backbone onto which a companion immunotherapy protocol will be offered An identical chemotherapy regimen will be offered to stage four patients as a backbone for a trial of retroviral transduction of the MDR1 and NeoR genes into harvested PBPCs
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-0032 | None | None | None |