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Azacytidine and Valproic Acid in Patients With Advanced Cancers

NCT00496444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2012-08-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Azacitidine

Starting Dose 20 mg/m\^2 administered subcutaneously (under the skin), daily, for ten days (Days 1 -10) of every 4 Week Cycle.

DRUG

Valproic Acid

Starting Dose 10 mg/Kg once daily by mouth, every day of 4 Week Cycle.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Razelle Kurzrock, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00496444 on ClinicalTrials.gov