Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002931
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
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 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 giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer
Detailed Description:
OBJECTIVES
Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer
Evaluate the toxic effects of paclitaxel carboplatin and etoposide VP-16 with stem cell support followed by paclitaxel carboplatin and ifosfamide with stem cell support in these patients
OUTLINE Patients receive filgrastim G-CSF SC or IV 4 days prior to peripheral blood stem cells PBSC apheresis Autologous bone marrow harvest is performed when adequate stem cells cannot be collected
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours On days -6 to -4 patients receive etoposide IV over 2 hours and carboplatin CBDCA IV over 30 minutes 3 times daily Following a 2 or 3 week recovery a second course of chemotherapy begins on day -7 consisting of paclitaxel IV over 24 hours then CBDCA and ifosfamide on days -6 to -4
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2 In addition G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000mm3 are maintained On day 0 stem cells with or without bone marrow product are again administered
Surgery may be performed after course 2 if indicated
PROJECTED ACCRUAL The expected accrual rate is 12 patients per year over 2 years
Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer
Evaluate the toxic effects of paclitaxel carboplatin and etoposide VP-16 with stem cell support followed by paclitaxel carboplatin and ifosfamide with stem cell support in these patients
OUTLINE Patients receive filgrastim G-CSF SC or IV 4 days prior to peripheral blood stem cells PBSC apheresis Autologous bone marrow harvest is performed when adequate stem cells cannot be collected
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours On days -6 to -4 patients receive etoposide IV over 2 hours and carboplatin CBDCA IV over 30 minutes 3 times daily Following a 2 or 3 week recovery a second course of chemotherapy begins on day -7 consisting of paclitaxel IV over 24 hours then CBDCA and ifosfamide on days -6 to -4
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2 In addition G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000mm3 are maintained On day 0 stem cells with or without bone marrow product are again administered
Surgery may be performed after course 2 if indicated
PROJECTED ACCRUAL The expected accrual rate is 12 patients per year over 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 |
|---|---|---|---|
| CDR0000065365 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-96126 | None | None | None |
| NCI-G97-1136 | None | None | None |