Status:
COMPLETED
Decitabine With or Without Valproic Acid in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Valproic acid may stop the gro...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the minimally effective pharmacological dose (MEPD) of single-agent decitabine in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. II. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed aggressive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
- Mantle cell lymphoma
- Diffuse large cell lymphoma
- Burkitt's lymphoma
- Transformed NHL\* arising from a previously diagnosed low-grade lymphoma, including any of the following:
- Follicular lymphoma
- Small lymphocytic lymphoma
- Chronic lymphocytic leukemia
- Relapsed or refractory disease
- Relapsed or refractory disease must have occurred during the most recent prior therapy
- Has accessible tissue for biopsy OR evidence of ≥ 50% bone marrow involvement AND willing to undergo serial biopsy
- Not eligible for OR refused curative stem cell transplantation
- No active or untreated CNS lymphoma
- Performance status - ECOG 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 75,000/mm\^3
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
- Creatinine ≤ 2.0 mg/dL
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No ongoing or active infection
- No other uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- Prior stem cell transplantation allowed
- Recovered from all prior biologic therapy-related toxicity
- Recovered from all prior chemotherapy-related toxicity
- No other concurrent chemotherapy unless it is used in the chronic daily setting for other medical conditions, including pulmonary, rheumatologic, or adrenal disorders
- No concurrent corticosteroids unless they are used in the chronic daily setting for other medical conditions, including pulmonary, rheumatologic, or adrenal disorders
- Recovered from all prior radiotherapy-related toxicity
- No concurrent palliative radiotherapy
- Recovered from all prior therapy-related toxicity
- No concurrent anticonvulsants, including valproic acid (except as used in this study)
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00109824
Start Date
March 1 2006
Last Update
June 4 2013
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210