Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002943
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
1999-11-01
Brief Title:
Carboplatin Etoposide Cyclophosphamide and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
High Dose Carboplatin Etoposide Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer A Phase II Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-08
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 autologous bone marrow transplantation may help the body kill more tumor cells
PURPOSE Phase II trial to study the effects of high doses of carboplatin etoposide and cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed or refractory germ cell cancer and other chemotherapy-sensitive solid tumors
PURPOSE Phase II trial to study the effects of high doses of carboplatin etoposide and cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed or refractory germ cell cancer and other chemotherapy-sensitive solid tumors
Detailed Description:
OBJECTIVES
Investigate the response rate duration of response survival time to marrow reconstitution and toxicity of two successive cycles of high dose carboplatin etoposide and cyclophosphamide chemotherapy and ABMT in patients with relapsed and refractory germ cell cancer or other chemotherapy-sensitive solid tumors
Further define the pretransplant characteristics of patients and their disease that might influence the outcome of this therapy
OUTLINE Patients receive carboplatin and etoposide for 5 days and cyclophosphamide for 2 days prior to ABMT
At day 60 following ABMT if the patient has a complete response CR or partial response PR and nonhematologic toxicity is no greater than grade 2 a second ABMT course is given when hematologic parameters and other criteria are acceptable If there is no CR or PR andor nonhematologic toxicity exceeds grade 2 a second ABMT is not given
After ABMT patients are followed until disease progression or death
PROJECTED ACCRUAL Ten patients will be accrued for this pilot study
Investigate the response rate duration of response survival time to marrow reconstitution and toxicity of two successive cycles of high dose carboplatin etoposide and cyclophosphamide chemotherapy and ABMT in patients with relapsed and refractory germ cell cancer or other chemotherapy-sensitive solid tumors
Further define the pretransplant characteristics of patients and their disease that might influence the outcome of this therapy
OUTLINE Patients receive carboplatin and etoposide for 5 days and cyclophosphamide for 2 days prior to ABMT
At day 60 following ABMT if the patient has a complete response CR or partial response PR and nonhematologic toxicity is no greater than grade 2 a second ABMT course is given when hematologic parameters and other criteria are acceptable If there is no CR or PR andor nonhematologic toxicity exceeds grade 2 a second ABMT is not given
After ABMT patients are followed until disease progression or death
PROJECTED ACCRUAL Ten patients will be accrued for this pilot study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-G97-1146 | None | None | None |
| CCCWFU-95193 | None | None | None |