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Azacytidine and Valproic Acid in Patients With Advanced Cancers

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: M.D. Anderson Cancer Center
Celgene Corporation
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00496444
  Purpose

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.

Condition Intervention Phase
Advanced Cancers
Drug: Azacitidine
Drug: Valproic acid
Phase I

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Azacitidine    Divalproex sodium    Valproate Sodium    Valproic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase I Study of Low-Dose Hypomethylating Agent Azacitidine Combined With the Histone Deacetylase Inhibitor Valproic Acid in Patients With Advanced Cancers

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:   68
Study Start Date:   May 2005

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. 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.
  2. There is no maximum allowable number of prior chemotherapy regimens, provided all other eligibility criteria are met.
  3. No chemotherapy, radiotherapy, investigational agents or surgery within four weeks.
  4. ECOG performance status 2 or less.
  5. Normal organ and marrow function - ANC > 1500/microL - Platelets > 100,000/microL - Total bilirubin < 2.0 mg/dL - Creatinine < 2.0 mg/dL
  6. 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.
  7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Uncontrolled concurrent illness such as neutropenic fever,shock, symptomatic congestive heart failure (NYHA class III or IV).
  2. Hypersensitivity to divalproex sodium, valproic acid, or valproate sodium
  3. Known or suspected hypersensitivity to azacitidine or mannitol.
  4. Nursing and pregnant women.
  5. 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).
  6. Patients with a known ornithine transcarbamylase disorder, history of unexplained coma or a family history of ornithine transcarbamylase disorder are excluded from this study.
  7. Patients younger than 2-year old since valproic acid safety is not proven in this age group.
  8. Leukemias and MDS are excluded
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496444

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation

Investigators
Principal Investigator:     Razelle Kurzrock, MD     U.T.M.D. Anderson Cancer Center    
  More Information


Study ID Numbers:   2004-0735
First Received:   July 2, 2007
Last Updated:   August 6, 2007
ClinicalTrials.gov Identifier:   NCT00496444
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers  
Azacytidine  
Valproic Acid  

Study placed in the following topic categories:
Azacitidine
Valproic Acid

Additional relevant MeSH terms:
Antimetabolites
Neurotransmitter Agents
Antimetabolites, Antineoplastic
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents
Pharmacologic Actions
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on October 06, 2008




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