Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Bryostatin 1 and Vincristine in Patients With Low or Intermediate Grade Non-Hodgkin's Lymphoma Progressing or Relapsing After a Prior Autologous Bone Marrow or Stem Cell Transplant
Phase II trial to study the effectiveness of combining bryostatin 1 with vincristine in treating patients who have progressive or relapsed non-Hodgkin's lymphoma after autologous bone marrow transplantation or autologous stem cell transplantation. Drugs used in chemotherapy such as vincristine use different ways to stop cancer cells from dividing so they stop growing or die. Bryostatin 1 may help vincristine kill more cancer cells by making the cells more sensitive to the drug
PRIMARY OBJECTIVES:
I. To evaluate response rate when bryostatin 1 is given in combination with vincristine in
patients with low and intermediate grade non-Hodgkin's lymphoma who have progressed or
relapsed following an autologous bone marrow or stem cell transplant.
II. To determine if blunting of apoptotic response (with two or more consecutive apoptotic
fractions) following treatment using annexin V staining of peripheral blood CD5+ and CD19+
lymphocytes by flow cytometry is predictive of outcome (i.e. lack of clinical response).
III. To prospectively evaluate the incidence of > grade 3 myelotoxicity with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV over 24 hours on days 1 and 15 and vincristine IV on days 2
and 16. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients without disease progression after 6 courses may continue therapy with bryostatin 1
IV over 24 hours on days 1 and 22 and vincristine IV on days 2 and 23. Courses repeat every
6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 2-5 years, and then
annually thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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