Decitabine With or Without Valproic Acid in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine together with valproic acid may be an effective treatment for non-Hodgkin's lymphoma. This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Azacitidine; Decitabine; Valproic Acid

Criteria

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)