Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004916
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-03-07
Brief Title:
Ifosfamide Teniposide and Paclitaxel in Treating Patients With Relapsed Non-Hodgkins Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase III Study of Mesna Ifosfamide Teniposide and Weekly Taxol MITTen in Relapsed Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-05
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 more than one drug may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of ifosfamide teniposide and paclitaxel in treating patients who have relapsed non-Hodgkins lymphoma
PURPOSE Phase III trial to study the effectiveness of ifosfamide teniposide and paclitaxel in treating patients who have relapsed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the toxicities associated with the combination of ifosfamide teniposide and weekly paclitaxel in patients with relapsed non-Hodgkins lymphoma
Evaluate response rate and time to disease progression in these patients treated with this regimen
OUTLINE This is a dose escalation study of teniposide Patients are stratified according to whether they proceed to stem cell transplant or not
Patients receive ifosfamide IV over 1-2 hours on days 1-3 every 3 weeks teniposide IV over 2 hours on day 1 every 3 weeks and paclitaxel IV over 1 hour weekly Patients who are not candidates for stem cell transplant continue treatment for 120 days in the absence of disease progression or unacceptable toxicity Patients proceeding to stem cell transplant continue treatment for 36 days Peripheral blood stem cells PBSC may be harvested at this time if autologous transplant is planned Transplant patients may then continue with chemotherapy or proceed to autologous or allogeneic PBSC transplant
Cohorts of 3-5 patients receive escalating doses of teniposide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 5 patients experience dose limiting toxicities
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 15-50 patients will be accrued for this study within 2 years
Determine the toxicities associated with the combination of ifosfamide teniposide and weekly paclitaxel in patients with relapsed non-Hodgkins lymphoma
Evaluate response rate and time to disease progression in these patients treated with this regimen
OUTLINE This is a dose escalation study of teniposide Patients are stratified according to whether they proceed to stem cell transplant or not
Patients receive ifosfamide IV over 1-2 hours on days 1-3 every 3 weeks teniposide IV over 2 hours on day 1 every 3 weeks and paclitaxel IV over 1 hour weekly Patients who are not candidates for stem cell transplant continue treatment for 120 days in the absence of disease progression or unacceptable toxicity Patients proceeding to stem cell transplant continue treatment for 36 days Peripheral blood stem cells PBSC may be harvested at this time if autologous transplant is planned Transplant patients may then continue with chemotherapy or proceed to autologous or allogeneic PBSC transplant
Cohorts of 3-5 patients receive escalating doses of teniposide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 5 patients experience dose limiting toxicities
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 15-50 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 |
|---|---|---|---|
| NCI-G00-1711 | None | None | None |
| NU-98H2 | None | None | None |