Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004162
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
1999-12-10
Brief Title:
Liposomal Doxorubicin Plus Combination Chemotherapy in Treating Patients With AIDS-Associated Non-Hodgkins Lymphoma
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Phase I Trial of Liposomal Doxorubicin Doxil Based Combination Chemotherapy Regimen in AIDS-Associated Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-04
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 I trial to study the effectiveness of liposomal doxorubicin plus combination chemotherapy in treating patients who have AIDS-associated non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of liposomal doxorubicin plus combination chemotherapy in treating patients who have AIDS-associated non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of doxorubicin HCl liposome when administered with combination chemotherapy in patients with AIDS-associated non-Hodgkins lymphoma II Determine the optimal phase II dose of doxorubicin HCl liposome to be administered with the combination chemotherapy regimen III Determine the effect of this regimen on HIV viral load in these patients IV Determine the clinical response to this regimen by these patients
OUTLINE This is a dose escalation study of doxorubicin HCl liposome Patients are stratified by risk group good vs poor Patients receive doxorubicin HCl liposome IV vincristine IV and methotrexate intrathecally on day 1 followed by oral prednisone on days 1-5 Sargramostim GM-CSF is administered subcutaneously on days 5-14 until blood counts recover Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 42-48 patients will be accrued for this study
OUTLINE This is a dose escalation study of doxorubicin HCl liposome Patients are stratified by risk group good vs poor Patients receive doxorubicin HCl liposome IV vincristine IV and methotrexate intrathecally on day 1 followed by oral prednisone on days 1-5 Sargramostim GM-CSF is administered subcutaneously on days 5-14 until blood counts recover Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 42-48 patients 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-G99-1627 | None | None | None |
| UAB-9708 | None | None | None |
| UAB-F970529007 | None | None | None |