Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003852
Status:
TERMINATED
Last Update Posted:
2016-06-23
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of patient inclusion
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 patients to tolerate higher doses of chemotherapy and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the complete response rate chemotherapy complete response pathological complete response or surgical complete response to intensive chemotherapy with autologous peripheral blood stem cell support in patients with cisplatin resistant germ cell tumors II Determine duration of complete response and survival of these patients after this therapy III Determine the toxic effects of this regimen in these patients IV Determine the pharmacokinetics of this regimen and the relationship between these pharmacokinetics nature and duration of response to treatment and the toxic effects in these patients
OUTLINE This is an open label multicenter study Patients receive epirubicin IV over 15 minutes and paclitaxel IV over 3 hours on day 1 then filgrastim G-CSF subcutaneously SQ on days 5-14 Peripheral blood stem cells PBSC are collected on days 13 and 14 This course is repeated beginning on day 15 Patients then undergo a three part intensification regimen Part I Patients receive cyclophosphamide IV and thiotepa IV by continuous infusion on days 34 and 35 PBSC are reinfused on day 38 and G-CSF SQ is administered from day 39 until blood cell counts recover Part II Patients receive etoposide IV over 2 hours ifosfamide IV over 4 hours and carboplatin IV over 6 hours on days 62-66 PBSC are reinfused on day 70 and eventually G-CSF begins on day 71 Part III Patients receive etoposide ifosfamide and carboplatin on days 90-94 as in part II PBSC are reinfused on day 98 and eventually G-CSF begins on day 99 Patients are followed every month for the first year every 2 months for the second year every 6 months for the third and fourth years then annually thereafter
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 2 years
OUTLINE This is an open label multicenter study Patients receive epirubicin IV over 15 minutes and paclitaxel IV over 3 hours on day 1 then filgrastim G-CSF subcutaneously SQ on days 5-14 Peripheral blood stem cells PBSC are collected on days 13 and 14 This course is repeated beginning on day 15 Patients then undergo a three part intensification regimen Part I Patients receive cyclophosphamide IV and thiotepa IV by continuous infusion on days 34 and 35 PBSC are reinfused on day 38 and G-CSF SQ is administered from day 39 until blood cell counts recover Part II Patients receive etoposide IV over 2 hours ifosfamide IV over 4 hours and carboplatin IV over 6 hours on days 62-66 PBSC are reinfused on day 70 and eventually G-CSF begins on day 71 Part III Patients receive etoposide ifosfamide and carboplatin on days 90-94 as in part II PBSC are reinfused on day 98 and eventually G-CSF begins on day 99 Patients are followed every month for the first year every 2 months for the second year every 6 months for the third and fourth years then annually thereafter
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| EU-99004 | None | None | None |
| FRE-FNCLCC-GETUG-04 | None | None | None |