Status:
COMPLETED
Bryostatin 1 and Rituximab in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Lead Sponsor:
National Institute on Aging (NIA)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 c...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00087425
Start Date
July 1 2004
Last Update
April 30 2015
Active Locations (1)
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1
NIH - Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892-1182