Phenylbutyrate in Treating Patients With Refractory Solid Tumors or Lymphoma

2014-07-23 21:57:07 | BioPortfolio


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectivenes of phenylbutyrate in treating adults with refractory solid tumor or lymphoma.


OBJECTIVES: I. Determine the maximum tolerated dose of oral phenylbutyrate that can be given three times daily in patients with refractory solid tumors or lymphoma until disease progression or a trough plasma concentration of 2-6 micromoles per liter is achieved. II. Characterize the pharmacokinetics of oral phenylbutyrate absorption, and determine whether there is time dependence in the systemic clearance rate during multiple dosing. III. Seek preliminary evidence of therapeutic activity of phenylbutyrate when administered on this schedule in these patients. IV. Correlate any observed responses and toxic effects with results of bioassays and tissue sampling for phenylbutyrate activity.

OUTLINE: This is a dose-seeking study. All patients receive oral phenylbutyrate three times daily. Groups of 4 or more patients receive escalating doses of phenylbutyrate until the maximum tolerated dose (MTD) is determined. Treatment continues until disease progression or unacceptable toxicity intervenes.

PROJECTED ACCRUAL: At least 4 patients are studied at each dose level. An additional 20 patients will be accrued at the maximum tolerated dose.

Study Design

Primary Purpose: Treatment




chemotherapy, oral sodium phenylbutyrate


Johns Hopkins Oncology Center
United States




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:57:07-0400

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