Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003388
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of Doxil Liposomal Doxorubicin Cyclophosphamide Vincristine and Prednisone for AIDS-Related Systemic Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 combination chemotherapy consisting of liposomal doxorubicin cyclophosphamide vincristine and prednisone in treating patients with AIDS-related lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin cyclophosphamide vincristine and prednisone in treating patients with AIDS-related lymphoma
Detailed Description:
OBJECTIVES I Determine the one year survival and complete response rate of patients treated with doxorubicin HCl liposomecyclophosphamidevincristineprednisone Doxil-CVP for AIDS-related lymphoma II Evaluate the toxicity of a combination chemotherapy regimen Doxil-CVP in this patient population III Evaluate the progression free and overall survival after treatment with Doxil-CVP in this patient population IV Evaluate the effects of treatment with Doxil-CVP on plasma viral mRNA levels CD4 lymphocyte count and the incidences and types of opportunistic infections in this patient population
OUTLINE Patients are stratified according to disease characteristics All patients receive a 30 minute infusion of doxorubicin HCl liposome IV cyclophosphamide IV and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 Filgrastim G-CSF is administered subcutaneously starting on day 6 and continues until the absolute neutrophil count is at least 10000mm3 Treatment courses are repeated every 21 days Patients with lymphomatous bone marrow involvement andor category J lymphoma receive cytarabine and methotrexate intrathecally weekly for 4 weeks Patients with lymphomatous meningitis receive whole brain irradiation and an alternating intrathecal chemotherapy regimen A minimum of 4 and a maximum of 8 courses are administered Patients are removed from the study for progressive disease stable disease after 4 courses a life threatening infection that would delay treatment for more than 6 weeks or any delay except due to neutropenia in chemotherapy treatment for more than 6 weeks Patients who achieve a complete response receive an additional 2 courses of therapy Patients are followed every 3 months for 2 years every 6 months for 3 years and annually thereafter
PROJECTED ACCRUAL A total of 38 patients will be accrued for this study
OUTLINE Patients are stratified according to disease characteristics All patients receive a 30 minute infusion of doxorubicin HCl liposome IV cyclophosphamide IV and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 Filgrastim G-CSF is administered subcutaneously starting on day 6 and continues until the absolute neutrophil count is at least 10000mm3 Treatment courses are repeated every 21 days Patients with lymphomatous bone marrow involvement andor category J lymphoma receive cytarabine and methotrexate intrathecally weekly for 4 weeks Patients with lymphomatous meningitis receive whole brain irradiation and an alternating intrathecal chemotherapy regimen A minimum of 4 and a maximum of 8 courses are administered Patients are removed from the study for progressive disease stable disease after 4 courses a life threatening infection that would delay treatment for more than 6 weeks or any delay except due to neutropenia in chemotherapy treatment for more than 6 weeks Patients who achieve a complete response receive an additional 2 courses of therapy Patients are followed every 3 months for 2 years every 6 months for 3 years and annually thereafter
PROJECTED ACCRUAL A total of 38 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 |
|---|---|---|---|
| E-3D97 | None | None | None |