Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003068
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
1999-11-01
Brief Title:
High-Dose Chemotherapy and Autologous Blood Cell Transplantation in Treating Patients With Primary Locally Advanced or Stage IV Breast Cancer
Sponsor:
University of Arizona
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Out Patient Dose Escalation Trial of High Dose Mitoxantrone Thiotepa and Cyclophosphamide Plus Autologous Blood Cell Rescue and Amifostine Cytoprotection
Status:
COMPLETED
Status Verified Date:
2006-05
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 may allow the doctor to give higher doses of chemotherapy and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of high-dose mitoxantrone thiotepa and cyclophosphamide plus autologous peripheral stem cell transplantation and amifostine in treating patients with primary locally advanced or stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of high-dose mitoxantrone thiotepa and cyclophosphamide plus autologous peripheral stem cell transplantation and amifostine in treating patients with primary locally advanced or stage IV breast cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated doses of mitoxantrone and cyclophosphamide when administered in combination with thiotepa autologous blood cells and amifostine in patients with primary locally advanced or metastatic breast cancer and determine whether amifostine a cytoprotection agent allows administration of high dose chemotherapy II Determine the dose limiting toxicities of this regimen when administered to patients with primary locally advanced or metastatic breast cancer III Evaluate the toxicities of amifostine a cytoprotection agent when administered in multiple doses to breast cancer patients receiving high dose chemotherapy and autologous blood cell transplantation IV Document the antitumor efficacy of this regimen versus freedom from recurrence and overall survival after autologous blood cell transplantation V Assess the contribution of disease treatment and personal characteristics affecting the quality of life in these patients and the patients primary caregiver
OUTLINE This is a dose escalation study Autologous blood cells are collected after completion of neoadjuvantinduction chemotherapy and salvage mastectomy if indicated Patients receive IV amifostine mitoxantrone and thiotepa on day -7 On day -6 patients receive IV amifostine thiotepa and cyclophosphamide treatment On days -5 -4 and -3 IV amifostine and cyclophosphamide are administered to participants Following high dose chemotherapy treatment patients rest on days -2 and -1 On day 0 patients undergo autologous blood cell transplantation Cohorts of 3 patients each receive escalating doses of mitoxantrone and cyclophosphamide If 1 of 3 patients at a given dose level experiences dose limiting toxicity DLT an additional 3 patients are treated at that dose If at least 3 of 6 patients experience DLT at a given dose level then the maximum tolerated dose is the previous dose level Patients are followed at day 100 then every 6 months for 2 years then annually until death
PROJECTED ACCRUAL A total of 30 patients will be accrued
OUTLINE This is a dose escalation study Autologous blood cells are collected after completion of neoadjuvantinduction chemotherapy and salvage mastectomy if indicated Patients receive IV amifostine mitoxantrone and thiotepa on day -7 On day -6 patients receive IV amifostine thiotepa and cyclophosphamide treatment On days -5 -4 and -3 IV amifostine and cyclophosphamide are administered to participants Following high dose chemotherapy treatment patients rest on days -2 and -1 On day 0 patients undergo autologous blood cell transplantation Cohorts of 3 patients each receive escalating doses of mitoxantrone and cyclophosphamide If 1 of 3 patients at a given dose level experiences dose limiting toxicity DLT an additional 3 patients are treated at that dose If at least 3 of 6 patients experience DLT at a given dose level then the maximum tolerated dose is the previous dose level Patients are followed at day 100 then every 6 months for 2 years then annually until death
PROJECTED ACCRUAL A total of 30 patients will be accrued
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 |
|---|---|---|---|
| UARIZ-HSC-9728 | None | None | None |
| ALZA-UARIZ-HSC-9728 | None | None | None |
| NCI-V97-1329 | None | None | None |