Non Hodgkin Lymphoma Clinical Trial
Bryostatin 1 and Rituximab in Treating Patients With B-Cell Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia
Summary
RATIONALE: Drugs used in chemotherapy, such as bryostatin 1, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Bryostatin 1 may help rituximab kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving bryostatin 1 together with rituximab works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia that has not responded to previous treatment with rituximab.
Full Description
OBJECTIVES:
Primary
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 leukemia (CLL).
Determine the antitumor response in patients treated with this regimen.
Secondary
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
One of the following histologically or cytologically confirmed diseases:
Indolent B-cell non-Hodgkin's lymphoma (NHL)
Stage II-IV disease
Chronic lymphocytic leukemia (CLL) meeting 1 of the following risk criteria:
Intermediate-risk with progressive disease
High-risk, modified Rai stage disease
CD20-positive by flow cytometry or immunohistochemistry
Measurable disease
Rituximab-refractory disease, defined as failure to achieve a response to the last course of prior treatment with rituximab alone or in combination with other therapeutic modalities
No known neoplastic leptomeningeal involvement and/or brain metastases
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2 OR
Karnofsky 60-100%
Life expectancy
More than 3 months
Hematopoietic
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 50,000/mm^3
WBC ≥ 3,000/mm^3
Hepatic
AST and ALT ≤ 2.5 times upper limit of normal
Bilirubin normal (unless due to Gilbert's disease or organ involvement by NHL or CLL)
Renal
Creatinine normal OR
Creatinine clearance ≥ 60 mL/min
Cardiovascular
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No history of anaphylaxis or immunoglobulin (Ig) E-mediated hypersensitivity to murine protein
Prior infusion reactions to rituximab without an IgE component allowed
No active or ongoing infection
No psychiatric illness or social situation that would preclude study compliance
No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
See Disease Characteristics
See Radiotherapy
At least 12 weeks since prior rituximab
More than 4 weeks since prior immunotherapy and recovered
Chemotherapy
No more than 3 prior chemotherapy regimens
More than 4 weeks since prior chemotherapy and recovered
Endocrine therapy
No concurrent glucocorticoids
Radiotherapy
At least 12 weeks since prior radioimmunotherapy
More than 4 weeks since prior radiotherapy and recovered
Surgery
Not specified
Other
At least 4 weeks since prior therapy for the malignancy
No other concurrent anticancer therapy
No other concurrent investigational agents
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Bethesda Maryland, 20892, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.