Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002578
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
1999-11-01
Brief Title:
Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkins Lymphoma
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Phase II Evaluation of Gallium Nitrate NSC 15200 in Non-Hodgkins Lymphoma in Patients With Acquired Immunodeficiency Syndrome
Status:
COMPLETED
Status Verified Date:
2015-10
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 Chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of gallium nitrate in treating patients with AIDS-related non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of gallium nitrate in treating patients with AIDS-related non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the response rate and duration of response in patients with AIDS-related non-Hodgkins lymphoma treated with gallium nitrate after failure on first-line chemotherapy regimen II Determine the qualitative and quantitative toxic effects of this regimen in these patients III Determine the pharmacokinetic parameters of this regimen in these patients and determine if there is a correlation between those parameters and response
OUTLINE Patients receive gallium nitrate IV continuously on days 1-7 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission CR receive 2 additional courses past CR Patients who relapse after achieving CR may be retreated in the absence of disease progression Treatment for relapse after a second CR is at the discretion of the principal investigator Patients with leptomeningeal disease at study entry must receive intrathecal IT methotrexate with IV leucovorin calcium or IT cytarabine Patients who develop leptomeningeal disease while on study may continue treatment with gallium nitrate but must also receive IT methotrexate and leucovorin calcium with or without radiotherapy or IT cytarabine Patients are followed for survival
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within 2 years
OUTLINE Patients receive gallium nitrate IV continuously on days 1-7 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission CR receive 2 additional courses past CR Patients who relapse after achieving CR may be retreated in the absence of disease progression Treatment for relapse after a second CR is at the discretion of the principal investigator Patients with leptomeningeal disease at study entry must receive intrathecal IT methotrexate with IV leucovorin calcium or IT cytarabine Patients who develop leptomeningeal disease while on study may continue treatment with gallium nitrate but must also receive IT methotrexate and leucovorin calcium with or without radiotherapy or IT cytarabine Patients are followed for survival
PROJECTED ACCRUAL A total of 20-35 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-T94-0043D | None | None | None |
| RPCI-DS-96-26 | None | None | None |
| UTHSC-9235011358 | None | None | None |