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
- 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.
- 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
- 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
- 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
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
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 2.5 years.
Primary Purpose: Treatment
Response to therapy as measured by overall, disease-free, and progression-free survival each month
Richard F. Little, MD
NCI - HIV and AIDS Malignancy Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|