Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006373
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2000-10-04
Brief Title:
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkins Lymphoma or Hodgkins Lymphoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Study of Intensive-Dose Topotecan IfosfamideMesna and Etoposide VepesidTIME Followed by Autologous Stem Cell Rescue in High Risk Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by autologous bone marrow transplantation or peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma or Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by autologous bone marrow transplantation or peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma or Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of intensive high dose chemotherapy consisting of topotecan ifosfamide and etoposide followed by autologous bone marrow or peripheral blood stem cell transplantation in terms of response rate progression free survival and overall survival in patients with high risk non-Hodgkins lymphoma or Hodgkins lymphoma
Determine the pharmacokinetic profile of high dose topotecan and etoposide in these patients
Determine the pharmacodynamics and toxicity of this regimen in these patients
Determine the role of either an up or down regulation of DNA topoisomerase I or II amount andor activity in terms of clinical response and toxicity in patients treated with this regimen
OUTLINE Patients receive intensive high dose chemotherapy consisting of ifosfamide IV over 2 hours followed by topotecan IV over 30 minutes on days -8 to -6 and etoposide IV continuously over 24 hours on days -5 to -3 Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0
Patients are followed at 3 6 and 12 months annually until disease relapse and then every 6 months until death
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 3 years
Determine the efficacy of intensive high dose chemotherapy consisting of topotecan ifosfamide and etoposide followed by autologous bone marrow or peripheral blood stem cell transplantation in terms of response rate progression free survival and overall survival in patients with high risk non-Hodgkins lymphoma or Hodgkins lymphoma
Determine the pharmacokinetic profile of high dose topotecan and etoposide in these patients
Determine the pharmacodynamics and toxicity of this regimen in these patients
Determine the role of either an up or down regulation of DNA topoisomerase I or II amount andor activity in terms of clinical response and toxicity in patients treated with this regimen
OUTLINE Patients receive intensive high dose chemotherapy consisting of ifosfamide IV over 2 hours followed by topotecan IV over 30 minutes on days -8 to -6 and etoposide IV continuously over 24 hours on days -5 to -3 Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0
Patients are followed at 3 6 and 12 months annually until disease relapse and then every 6 months until death
PROJECTED ACCRUAL A total of 40 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 |
|---|---|---|---|
| NCI-G00-1865 | None | None | None |
| MCC-12246 | None | None | None |
| MCC-IRB-5670 | None | None | None |
| SB-MCC-12246 | None | None | None |