Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310128
Status:
WITHDRAWN
Last Update Posted:
2016-02-03
First Post:
2006-03-29
Brief Title:
Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkins Lymphoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
Phase II Study of Induction Therapy Comprising Etoposide Methylprednisolone Cytarabine and Cisplatin ESHAP Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkins Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug supply unavailable
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 such as etoposide methylprednisolone cytarabine and cisplatin work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells Giving more than one drug combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed or refractory AIDS-related non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed or refractory AIDS-related non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the overall survival rate at one year in patients with relapsed or refractory AIDS-related non-Hodgkins lymphoma treated with consolidation therapy comprising rituximab and yttrium Y 90 ibritumomab tiuxetan radioimmunotherapy given after induction therapy comprising etoposide methylprednisolone cytarabine and cisplatin ESHAP
Describe the toxicity profile of radioimmunotherapy as consolidation therapy including changes in immunologic and virologic parameters over time in these patients
Determine the overall disease-free survival of patients receiving ESHAP as induction therapy followed by radioimmunotherapy as consolidation therapy
Secondary
Determine the effect of ESHAP as induction therapy and radioimmunotherapy as consolidation therapy on HIV-1 viral load CD4 and CD8 cells and quantitative immunoglobulin levels in patients on concurrent highly active antiretroviral therapy HAART
Determine the objective response rates complete and partial response in patients treated with this regimen
Determine the toxicity of ESHAP as induction therapy in these patients
OUTLINE This is a multicenter study
Induction therapy Patients receive ESHAP chemotherapy comprising etoposide IV over 2 hours on days 1-4 methylprednisolone IV over 15-30 minutes on days 1-5 cisplatin IV continuously over 96 hours on days 1-4 and cytarabine IV over 2 hours on day 5 Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Approximately 21-52 days after completion of ESHAP chemotherapy patients proceed to consolidation therapy
Consolidation therapy Patients receive radioimmunotherapy comprising rituximab IV over 3-4 hours followed by indium In 111 ibritumomab tiuxetan for radioimaging IV over 10 minutes on day 1 Patients then undergo imaging on days 1 and 2 If biodistribution is acceptable patients receive rituximab IV over 3-4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8
After completing study treatment patients are followed every 2 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study
Primary
Determine the overall survival rate at one year in patients with relapsed or refractory AIDS-related non-Hodgkins lymphoma treated with consolidation therapy comprising rituximab and yttrium Y 90 ibritumomab tiuxetan radioimmunotherapy given after induction therapy comprising etoposide methylprednisolone cytarabine and cisplatin ESHAP
Describe the toxicity profile of radioimmunotherapy as consolidation therapy including changes in immunologic and virologic parameters over time in these patients
Determine the overall disease-free survival of patients receiving ESHAP as induction therapy followed by radioimmunotherapy as consolidation therapy
Secondary
Determine the effect of ESHAP as induction therapy and radioimmunotherapy as consolidation therapy on HIV-1 viral load CD4 and CD8 cells and quantitative immunoglobulin levels in patients on concurrent highly active antiretroviral therapy HAART
Determine the objective response rates complete and partial response in patients treated with this regimen
Determine the toxicity of ESHAP as induction therapy in these patients
OUTLINE This is a multicenter study
Induction therapy Patients receive ESHAP chemotherapy comprising etoposide IV over 2 hours on days 1-4 methylprednisolone IV over 15-30 minutes on days 1-5 cisplatin IV continuously over 96 hours on days 1-4 and cytarabine IV over 2 hours on day 5 Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Approximately 21-52 days after completion of ESHAP chemotherapy patients proceed to consolidation therapy
Consolidation therapy Patients receive radioimmunotherapy comprising rituximab IV over 3-4 hours followed by indium In 111 ibritumomab tiuxetan for radioimaging IV over 10 minutes on day 1 Patients then undergo imaging on days 1 and 2 If biodistribution is acceptable patients receive rituximab IV over 3-4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8
After completing study treatment patients are followed every 2 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000467797 | OTHER | NCI | None |