Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049439
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2002-11-12
Brief Title:
Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkins Lymphoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkins Lymphoma In The United States And Africa
Status:
COMPLETED
Status Verified Date:
2010-06
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 Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining lomustine etoposide cyclophosphamide and procarbazine in treating patients who have AIDS-related non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combining lomustine etoposide cyclophosphamide and procarbazine in treating patients who have AIDS-related non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the objective response rate response duration and survival of patients with AIDS-related non-Hodgkins lymphoma treated with lomustine etoposide cyclophosphamide and procarbazine
Determine the feasibility of this regimen in these patients
Determine the clinical toxicity of this regimen in these patients
Assess the quality of life of patients treated with this regimen
Determine the impact of this regimen on the underlying HIV infection in these patients
OUTLINE This is a multicenter study
Patients receive oral lomustine on day 1 course 1 only oral etoposide on days 1-3 and oral cyclophosphamide and oral procarbazine on days 22-26 Patients may also receive filgrastim G-CSF subcutaneously on days 5-21 and 28-42 Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on days 1 and 22 of each course at day 84 and then every 3 months for 1 year
Patients are followed at day 84 and then every 3 months
PROJECTED ACCRUAL A total of 66 patients 22 in the United States and 44 in Africa will be accrued for this study within 3-4 years
Determine the objective response rate response duration and survival of patients with AIDS-related non-Hodgkins lymphoma treated with lomustine etoposide cyclophosphamide and procarbazine
Determine the feasibility of this regimen in these patients
Determine the clinical toxicity of this regimen in these patients
Assess the quality of life of patients treated with this regimen
Determine the impact of this regimen on the underlying HIV infection in these patients
OUTLINE This is a multicenter study
Patients receive oral lomustine on day 1 course 1 only oral etoposide on days 1-3 and oral cyclophosphamide and oral procarbazine on days 22-26 Patients may also receive filgrastim G-CSF subcutaneously on days 5-21 and 28-42 Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on days 1 and 22 of each course at day 84 and then every 3 months for 1 year
Patients are followed at day 84 and then every 3 months
PROJECTED ACCRUAL A total of 66 patients 22 in the United States and 44 in Africa will be accrued for this study within 3-4 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 |
|---|---|---|---|
| CASE-2498 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-029828J | None | None | None |
| CWRU-2498 | None | None | None |
| NCI-G02-2126 | None | None | None |