Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003143
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Amifostine in Treating Patients With Recurrent or Refractory Non-Hodgkins Lymphoma or Hodgkins Disease Undergoing Stem Cell Transplantation
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Randomized Study of Ethyol Amifostine With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2012-10
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy with or without amifostine in treating patients with recurrent or refractory non-Hodgkins lymphoma or Hodgkins disease who are undergoing autologous stem cell transplantation
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy with or without amifostine in treating patients with recurrent or refractory non-Hodgkins lymphoma or Hodgkins disease who are undergoing autologous stem cell transplantation
Detailed Description:
OBJECTIVES I Evaluate the role of amifostine in reducing hematologic toxicity and improving mobilization of peripheral progenitor stem cells in patients with recurrent or refractory non-Hodgkins lymphoma or Hodgkins disease who are undergoing platinum based salvage chemotherapy II Evaluate the role of amifostine in preventing renal toxicity in these patients
OUTLINE This is an randomized open label study Patients are randomized to receive salvage chemotherapy with intravenous dexamethasonecisplatincytarabine DHAP with or without amifostine Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses Patients also receive dexamethasone orally or IV Treatment repeats every 3-4 weeks for 2-6 courses Arm I Patients receive amifostine IV over 15 minutes prior to all courses of DHAP as a 15 minute infusion beginning 30 minutes prior to cisplatin administration Arm II Patients do not receive amifostine On day 3 of the last DHAP course patients receive filgrastim G-CSF until the last day of progenitor stem cell PSC mobilization PSC transplant continues daily for 4-10 days
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study
OUTLINE This is an randomized open label study Patients are randomized to receive salvage chemotherapy with intravenous dexamethasonecisplatincytarabine DHAP with or without amifostine Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses Patients also receive dexamethasone orally or IV Treatment repeats every 3-4 weeks for 2-6 courses Arm I Patients receive amifostine IV over 15 minutes prior to all courses of DHAP as a 15 minute infusion beginning 30 minutes prior to cisplatin administration Arm II Patients do not receive amifostine On day 3 of the last DHAP course patients receive filgrastim G-CSF until the last day of progenitor stem cell PSC mobilization PSC transplant continues daily for 4-10 days
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study
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-V97-1362 | None | None | None |
| UCLA-HSPC-970708701 | None | None | None |
| ALZA-UCLA-HSPC-970708701 | None | None | None |