Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005824
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2000-06-02
Brief Title:
Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-02
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 Peripheral stem cell 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 chemotherapy followed by peripheral stem cell transplantation in treating patients who have recurrent or refractory AIDS-related lymphoma
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have recurrent or refractory AIDS-related lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of intensive chemotherapy and autologous peripheral blood stem cell transplantation in patients with recurrent or refractory AIDS-related lymphoma
Determine the response and response duration in these patients treated with this regimen
Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these patients
OUTLINE Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2 hours followed 2 days later by daily filgrastim G-CSF subcutaneously SC until blood counts recover Patients then undergo leukopheresis to collect CD34 cells
Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days -7 -6 -5 and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3 and -2 Patients undergo autologous stem cell infusion on day 0 G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover
Patients are followed monthly for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 5-25 patients will be accrued for this study
Determine the safety and tolerability of intensive chemotherapy and autologous peripheral blood stem cell transplantation in patients with recurrent or refractory AIDS-related lymphoma
Determine the response and response duration in these patients treated with this regimen
Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these patients
OUTLINE Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2 hours followed 2 days later by daily filgrastim G-CSF subcutaneously SC until blood counts recover Patients then undergo leukopheresis to collect CD34 cells
Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days -7 -6 -5 and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3 and -2 Patients undergo autologous stem cell infusion on day 0 G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover
Patients are followed monthly for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 5-25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067835 | OTHER | NCI | None |