Azacytidine and Valproic Acid in Patients With Advanced Cancers

Completed · Phase 1

Conditions studied: Advanced Cancers

In brief

Primary Objective: 1\. To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in patients with advanced cancer. Secondary Objectives: 1. To perform a preliminary assessment of the histone acetylation and DNA methylation effects of this combination on peripheral blood mononuclear cells (PBMC). 2. To assess the clinical anti-tumor activity (objective response including complete and partial responses) of this combination in patients with advanced cancer, in a descriptive fashion.

Key facts

Study ID

NCT00496444

Run by

M.D. Anderson Cancer Center

People needed

69

Starts

2005-05-01

Expected to finish

2009-10-01

Last updated by the study team

2012-08-01

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with pathologically confirmed malignancy that is metastatic or unresectable and refractory to standard therapy or for whom there is no standard therapy that induces complete remission (CR) of at least 10% or an increased survival of at least 3 months.
• There is no maximum allowable number of prior chemotherapy regimens, provided all other eligibility criteria are met.
• No chemotherapy, radiotherapy, investigational agents or surgery within four weeks.
• ECOG performance status 2 or less.
• Normal organ and marrow function - ANC > 1500/microL - Platelets > 100,000/microL - Total bilirubin < 2.0 mg/dL - Creatinine < 2.0 mg/dL
• The effect of azacytidine on the development of human fetus is unknown. Because of the chemotherapy agents are known to be teratogenic, women and men of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of the study.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Uncontrolled concurrent illness such as neutropenic fever,shock, symptomatic congestive heart failure (NYHA class III or IV).
• Hypersensitivity to divalproex sodium, valproic acid, or valproate sodium
• Known or suspected hypersensitivity to azacitidine or mannitol.
• Nursing and pregnant women.
• Patients with urea cycle disorders (UCD): - History of unexplained coma, encephalopathy, or mental retardation - Encephalopathy associated with a protein load - Pregnancy-related or postpartum encephalopathy - History of elevated plasma ammonia or glutamine - Those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance. - Those with a family history of UCD or unexplained infant deaths (particularly males).
• Patients with a known ornithine transcarbamylase disorder, history of unexplained coma or a family history of ornithine transcarbamylase disorder are excluded from this study.
• Patients younger than 2-year old since valproic acid safety is not proven in this age group.
• Leukemias and MDS are excluded

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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