Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003575
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Brief Title:
Interleukin-12 Following Chemotherapy in Treating Patients With Refractory HIV-Associated Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Pre-Phase II Trial of Interleukin-2 Interleukin-12 or No Additional Therapy Following Response to IfosfamideEtoposide Chemotherapy for Refractory HIV-Associated Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2002-10
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:
Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in treating patients who have refractory HIV-associated non-Hodgkins lymphoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person white blood cells to kill cancer cells
Detailed Description:
OBJECTIVES
I Determine the efficacy of interleukin-12 IL-12 by evaluating its effect on remission duration after response to second line chemotherapy with ifosfamide and etoposide in patients with HIV-associated non-Hodgkins lymphoma
II Determine the safety of IL-12 when administered as maintenance therapy in these patients
III Evaluate overall survival of this patient population IV Evaluate serum and tissue cytokine levels in these patients V Evaluate the effect of IL-12 on HIV viral load and on functional T-cell assays in these patients
VI Evaluate the effect of IL-12 on Epstein-Barr Virus EBV viral load in these patients
OUTLINE This is an open label study
All patients receive ifosfamide IV by continuous infusion for 2 days etoposide IV over 2 hours daily on days 1 and 2 and filgrastim G-CSF subcutaneously SC daily on days 4-13 Courses are repeated every 21 days Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression All patients also receive combination antiretroviral therapy during study
Patients are followed every month for one year then every 2 months thereafter
I Determine the efficacy of interleukin-12 IL-12 by evaluating its effect on remission duration after response to second line chemotherapy with ifosfamide and etoposide in patients with HIV-associated non-Hodgkins lymphoma
II Determine the safety of IL-12 when administered as maintenance therapy in these patients
III Evaluate overall survival of this patient population IV Evaluate serum and tissue cytokine levels in these patients V Evaluate the effect of IL-12 on HIV viral load and on functional T-cell assays in these patients
VI Evaluate the effect of IL-12 on Epstein-Barr Virus EBV viral load in these patients
OUTLINE This is an open label study
All patients receive ifosfamide IV by continuous infusion for 2 days etoposide IV over 2 hours daily on days 1 and 2 and filgrastim G-CSF subcutaneously SC daily on days 4-13 Courses are repeated every 21 days Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression All patients also receive combination antiretroviral therapy during study
Patients are followed every month for one year then every 2 months thereafter
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 |
|---|---|---|---|
| CDR0000066642 | REGISTRY | PDQ Physician Data Query | None |
| AMC-008 | None | None | None |