Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054808
Status:
COMPLETED
Last Update Posted:
2006-02-08
First Post:
2003-02-10
Brief Title:
Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Genta Incorporated
Organization:
Genta Incorporated
Study Overview
Official Title:
A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Eligible patients will have low- or intermediate-grade Non-Hodgkins Lymphoma NHL that has progressed after standard chemotherapy Patients will receive gallium nitrate 300 mgm2day by continuous IV infusion for 7 consecutive days using a portable infusion pump Hospitalization is not required Stable or responding patients will receive additional gallium nitrate infusions every 3 weeks until the time of disease progression for a maximum total of 8 infusions or 2 cycles after complete remission has been documented
Detailed Description:
This study seeks to define the role of gallium nitrate in a specific population of patients who are expected to have received prior therapy Preliminary clinical studies have suggested substantial evidence of antitumor activity in patients with relapsed or refractory non-Hodgkins Lymphoma treated with gallium nitrate
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