Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217503
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2005-09-20
Brief Title:
Bortezomib and Antiviral Therapy Followed By Effusion Drainage Bevacizumab and Combination Chemotherapy in Treating Patients With Primary Effusion Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Primary Effusion Lymphoma A Pilot Trial of Bevacizumab and Modified Dose-Adjusted Infusional CDE Chemotherapy Preceded by a Brief Pre-Phase Assessment of Targeted Oncolytic Virotherapy With Bortezomib Zidovudine and Valganciclovir
Status:
COMPLETED
Status Verified Date:
2007-04
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 Herpesvirus is found in the cancer cells of patients with primary effusion lymphoma Antiviral drugs such as zidovudine and valganciclovir may be able to act against the herpesvirus in the cancer cells to help kill the cancer cells Bortezomib may help the antiviral drugs kill the cancer cells Draining the effusion removes fluid that has built up Monoclonal antibodies such as bevacizumab 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 Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer Drugs used in chemotherapy such as cyclophosphamide doxorubicin and etoposide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving bortezomib together with antiviral therapy followed by effusion drainage bevacizumab and combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving bortezomib together with antiviral therapy followed by effusion drainage bevacizumab and combination chemotherapy works in treating patients with primary effusion lymphoma
PURPOSE This phase II trial is studying how well giving bortezomib together with antiviral therapy followed by effusion drainage bevacizumab and combination chemotherapy works in treating patients with primary effusion lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the complete response rate in patients with previously untreated primary effusion lymphoma treated with effusion drainage and bevacizumab in combination with chemotherapy comprising cyclophosphamide doxorubicin and etoposide
Secondary
Determine the overall survival disease-free survival and progression-free survival of patients treated with this regimen
Determine the toxicity of this regimen in previously treated or untreated patients
Determine preliminarily the biologic effects of targeted oncolytic virotherapy comprising bortezomib zidovudine and valganciclovir in these patients
OUTLINE This is a 2-part pilot study
Patients who are HIV-positive receive highly-active antiretroviral therapy during study treatment
Part 1 targeted oncolytic virotherapy Patients receive bortezomib IV over 3-5 seconds on days 1 4 and 8 zidovudine IV over 1 hour twice daily on days 1-10 and oral valganciclovir or ganciclovir IV twice daily on days 1-14 One day after completion of zidovudine patients begin treatment in part 2
NOTE Part 1 treatment may be omitted in patients who are acutely ill with primary effusion lymphoma at study entry AND a 10- to 14-day delay of starting part 2 treatment may pose a hazard to the patient
Part 2
Effusion drainage Patients undergo effusion drainage prior to each course of bevacizumab and chemotherapy The drainage tube may remain in place to allow for continuous drainage of effusion during treatment with bevacizumab and chemotherapy
Bevacizumab plus cyclophosphamide doxorubicin and etoposide iCDE Patients receive bevacizumab IV over 30-90 minutes on days 1 and 6 cyclophosphamide doxorubicin and etoposide IV continuously over 96 hours beginning on day 1 and continuing until day 5 and filgrastim G-CSF subcutaneously SC daily beginning on day 6 and continuing until day 19 or until blood counts recover OR pegfilgrastim SC on day 6
NOTE Patients may receive iCDE without bevacizumab if they meet any exclusion criteria for receiving bevacizumab
Treatment with bevacizumab and iCDE repeats every 21 days for 4-8 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond CR
After completion of study treatment patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 25 years
Primary
Determine the complete response rate in patients with previously untreated primary effusion lymphoma treated with effusion drainage and bevacizumab in combination with chemotherapy comprising cyclophosphamide doxorubicin and etoposide
Secondary
Determine the overall survival disease-free survival and progression-free survival of patients treated with this regimen
Determine the toxicity of this regimen in previously treated or untreated patients
Determine preliminarily the biologic effects of targeted oncolytic virotherapy comprising bortezomib zidovudine and valganciclovir in these patients
OUTLINE This is a 2-part pilot study
Patients who are HIV-positive receive highly-active antiretroviral therapy during study treatment
Part 1 targeted oncolytic virotherapy Patients receive bortezomib IV over 3-5 seconds on days 1 4 and 8 zidovudine IV over 1 hour twice daily on days 1-10 and oral valganciclovir or ganciclovir IV twice daily on days 1-14 One day after completion of zidovudine patients begin treatment in part 2
NOTE Part 1 treatment may be omitted in patients who are acutely ill with primary effusion lymphoma at study entry AND a 10- to 14-day delay of starting part 2 treatment may pose a hazard to the patient
Part 2
Effusion drainage Patients undergo effusion drainage prior to each course of bevacizumab and chemotherapy The drainage tube may remain in place to allow for continuous drainage of effusion during treatment with bevacizumab and chemotherapy
Bevacizumab plus cyclophosphamide doxorubicin and etoposide iCDE Patients receive bevacizumab IV over 30-90 minutes on days 1 and 6 cyclophosphamide doxorubicin and etoposide IV continuously over 96 hours beginning on day 1 and continuing until day 5 and filgrastim G-CSF subcutaneously SC daily beginning on day 6 and continuing until day 19 or until blood counts recover OR pegfilgrastim SC on day 6
NOTE Patients may receive iCDE without bevacizumab if they meet any exclusion criteria for receiving bevacizumab
Treatment with bevacizumab and iCDE repeats every 21 days for 4-8 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond CR
After completion of study treatment patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 25 years
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 |
|---|---|---|---|
| NCI-P6330 | None | None | None |
| NCI-05-C-0203 | None | None | None |