Track topics on Twitter Track topics that are important to you
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
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.
Primary Purpose: Treatment
chemotherapy, oral sodium phenylbutyrate
Johns Hopkins Oncology Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:57:07-0400
The investigators will study and compare how effectively sodium phenylbutyrate, sodium benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject particip...
The purpose of the study is to evaluate the safety of sodium phenylbutyrate (NaPB) treatment in subjects with amyotrophic lateral sclerosis (ALS) and the ability to take this medication wi...
The purpose of this study is to evaluate the safety, tolerability and clinical impact of 15-grams daily of sodium phenylbutyrate (phenylbutyrate) in Huntington's disease and to lay the gro...
OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
The purpose of this study is to identify the maximum tolerated dosage of sodium phenylbutyrate in children with spinal muscular atrophy types II or III; and to determine if the drug has an...
The pathogenic fungus Candida albicans (C. albicans) is one of the most commonly clinically isolated fungal species and its resistance to the antifungal drug fluconazole is known to be increasing. In ...
Anaplastic large cell lymphoma (ALCL) is a very rare subtype of T-cell non-Hodgkin's lymphoma (NHL). Similar to other types of NHL, ALCL primarily involves the nodal areas and sometimes it can involve...
Pediatric patients with acute lymphoblastic leukemia (ALL) usually develop oral manifestations due to the disease itself, as well as side effects of chemotherapy that severely affect their health and ...
This review aimed to analyze the scientific production on severity of oral mucositis as an adverse effect of chemotherapy. To this end, we performed a search at PubMed databases combining the keywords...
To report a patient who developed unilateral corneal stromal infiltration while undergoing systemic chemotherapy for multinodal peripheral T-cell lymphoma not otherwise specified.
Malignant lymphoma composed of large B lymphoid cells which have the immunophenotype of plasma cells and a predilection for the ORAL CAVITY.
Drug treatment designed to further diminish the disease toward complete remission following INDUCTION CHEMOTHERAPY. It helps to consolidate the gains during induction chemotherapy and may be followed by MAINTENANCE CHEMOTHERAPY.
Treatment designed to help prevent a relapse of a disease following the successful primary treatments (INDUCTION CHEMOTHERAPY and CONSOLIDATION CHEMOTHERAPY) with a long-term low-dose drug therapy.
Initial drug treatment designed to bring about REMISSION INDUCTION. It is typically a short-term and high-dose drug treatment that is followed by CONSOLIDATION CHEMOTHERAPY and then MAINTENANCE CHEMOTHERAPY.
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...