A Phase II Trial Of Bryostatin-1 In Combination With Rituximab In Rituximab-Refractory Indolent B-cell Non Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia
- Determine the feasibility and safety of bryostatin 1 and rituximab in patients with
rituximab-refractory indolent B-cell non-Hodgkin's lymphoma or chronic lymphocytic
- Determine the antitumor response in patients treated with this regimen.
- Determine the effects of this regimen on the functional and molecular status of
effector cells (i.e., NK cells, monocytes, and dendritic cells) in these patients.
- Determine the expression of CD20 and complement-inhibitory molecules on tumor cells
before and after treatment with this regimen in these patients.
- Determine the effects of this regimen on the global gene expression pattern in CLL
cells of these patients.
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV continuously over 24 hours on days -6, 2, and 9 of course 1
and on days 2 and 9 of courses 2-6. Patients also receive rituximab IV over 4 hours on days
1, 8, 15, and 22 of courses 1 and 4. Treatment repeats every 28 days for 6 courses in the
absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 18-48 patients (9-24 with non-Hodgkin's lymphoma and 9-24
with chronic lymphocytic leukemia) will be accrued for this study within 12-30 months.
Masking: Open Label, Primary Purpose: Treatment
Feasability and safety
Igor Espinoza-Delgado, MD
Gerontology Research Center
United States: Food and Drug Administration
|NIH - Warren Grant Magnuson Clinical Center||Bethesda, Maryland 20892-1182|