Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002601
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
High-Dose Doxorubicin and Ifosfamide Followed by Melphalan and Cisplatin for Patients With High-Risk and Recurrent Sarcoma
Status:
COMPLETED
Status Verified Date:
2017-01
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients who have advanced or recurrent sarcoma
PURPOSE Phase II trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients who have advanced or recurrent sarcoma
Detailed Description:
OBJECTIVES I Determine the feasibility of sequential high-dose chemotherapy with ifosfamide and doxorubicin followed by melphalan and cisplatin each followed by autologous peripheral blood stem cell support in patients with high-risk or advanced sarcomas II Determine the toxic effects of this regimen in these patients III Determine response rate and disease-free and overall survival in these patients treated with this regimen
OUTLINE Beginning at least 4 weeks prior to the start of chemotherapy patients receive filgrastim G-CSF subcutaneously daily until the completion of peripheral blood stem cell PBSC harvesting Beginning 5 days after the start of G-CSF PBSCs are collected over several days Patients who do not mobilize sufficient cells undergo bone marrow harvest Regimen A Patients receive high-dose ifosfamide IV and doxorubicin IV continuously over 96 hours on days -8 to -4 125 of PBSCs or bone marrow are reinfused on day -2 and 375 are reinfused on day 0 Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover Regimen B Beginning at least 4 weeks after day 1 of Regimen A patients receive high-dose melphalan IV followed immediately by cisplatin IV on days -11 and -4 Patients receive G-CSF IV on days -10 to -6 125 of PBSCs or bone marrow are reinfused on day -3 and the remaining 375 are reinfused on day 0 Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover Patients are followed monthly for 1 year every 3 months for 1 year and then as needed for 3 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 years
OUTLINE Beginning at least 4 weeks prior to the start of chemotherapy patients receive filgrastim G-CSF subcutaneously daily until the completion of peripheral blood stem cell PBSC harvesting Beginning 5 days after the start of G-CSF PBSCs are collected over several days Patients who do not mobilize sufficient cells undergo bone marrow harvest Regimen A Patients receive high-dose ifosfamide IV and doxorubicin IV continuously over 96 hours on days -8 to -4 125 of PBSCs or bone marrow are reinfused on day -2 and 375 are reinfused on day 0 Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover Regimen B Beginning at least 4 weeks after day 1 of Regimen A patients receive high-dose melphalan IV followed immediately by cisplatin IV on days -11 and -4 Patients receive G-CSF IV on days -10 to -6 125 of PBSCs or bone marrow are reinfused on day -3 and the remaining 375 are reinfused on day 0 Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover Patients are followed monthly for 1 year every 3 months for 1 year and then as needed for 3 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000063845 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-IRB-94072 | REGISTRY | None | None |
| NCI-V94-0545 | None | None | None |