Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002508
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
INTENSIVE CHEMOTHERAPY FOR RELAPSED OR REFRACTORY GERM CELL TUMORS EMPLOYING HIGH-DOSE CARBOPLATIN ETOPOSIDE AND THIOTEPA WITH AUTOLOGOUS BONE MARROW RESCUE FOR PATIENTS 15 TO 60 YEARS OF AGE
Status:
COMPLETED
Status Verified Date:
2010-09
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 Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have relapsed or recurrent germ cell cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have relapsed or recurrent germ cell cancer
Detailed Description:
OBJECTIVES I Determine the response rate overall survival and disease-free survival of patients with refractory or relapsed germ cell carcinoma treated with high-dose induction chemotherapy comprising carboplatin and etoposide followed by autologous bone marrow or peripheral blood stem cell rescue
OUTLINE Autologous peripheral blood stem cells PBSC or bone marrow is harvested Patients receive carboplatin IV continuously and etoposide IV over 1 hour on days -5 through -3 Autologous PBSC or bone marrow is reinfused on day 0
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
OUTLINE Autologous peripheral blood stem cells PBSC or bone marrow is harvested Patients receive carboplatin IV continuously and etoposide IV over 1 hour on days -5 through -3 Autologous PBSC or bone marrow is reinfused on day 0
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| TUHSC-1839 | None | None | None |
| NCI-V92-0204 | None | None | None |