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

Completed · Phase 1

Conditions studied: Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00109824

Run by

National Cancer Institute (NCI)

People needed

42

Starts

2006-03-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.