Hydralazine and Valproate Added to Chemotherapy for Breast Cancer

NCT00395655 | Terminated Phase 2

• 1 other identifier: 005/012/ICI
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Aberrant DNA methylation and histone deacetylation participate in cancer development and progression, as epigenetic alterations are common to breast cancer, in this phase II study, the demethylating hydralazine plus the HDAC inhibitor magnesium valproate will be added to neoadjuvant doxorubicin and cyclophosphamide in locally advanced breast cancer to assess their safety and biological efficacy.

Conditions

Locally Advanced Breast Cancer

Keywords

locally advanced breast cancer; hydralazine; magnesium valproate; epigenetic therapy; gene expression

Outcome Measures

Primary Outcomes (3)

• Global DNA methylation

• Histone Deacetylase Activity

• Global gene expression

Secondary Outcomes (3)

• Pathological response

• Hydralazine plasma levels

• Valproic acid plasma levels

Interventions

Hydralazine and magnesium valproate administration DRUG

Core-needle biopsy of the breast PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and older; histologically proven invasive T2-3, N0-2, and M0 (stages IIB-IIIA) breast carcinoma; Eastern Cooperative Oncology Group performance status ≤2. Hematological function: Absolute leukocyte count ≥4,000/mm3, platelets ≥100,000/mm3, hemoglobin ≥9.0 g/dL. Hepatic function: total bilirubin, aspartate amino transferase and alanine amino transferase \<1.5 the upper normal limit. Renal function: creatinine ≤1.2 mg/dL or a calculated creatinine clearance of ≥60 mL/min. Written informed consent.

You may not qualify if:

• A history of allergy to sulphas, hydralazine, or magnesium valproate. Past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician. Previous use of the experimental drugs. Pregnancy and breast-feeding. Uncontrolled systemic disease or infection.

Sponsors & Collaborators

• National Institute of Cancerología: lead
• National Council of Science and Technology, Mexico: collaborator
• Psicofarma, S.A. De C.V.: collaborator

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, TLALPAN, 14080, Mexico

Location

Related Publications (1)

• Arce C, Perez-Plasencia C, Gonzalez-Fierro A, de la Cruz-Hernandez E, Revilla-Vazquez A, Chavez-Blanco A, Trejo-Becerril C, Perez-Cardenas E, Taja-Chayeb L, Bargallo E, Villarreal P, Ramirez T, Vela T, Candelaria M, Camargo MF, Robles E, Duenas-Gonzalez A. A proof-of-principle study of epigenetic therapy added to neoadjuvant doxorubicin cyclophosphamide for locally advanced breast cancer. PLoS One. 2006 Dec 20;1(1):e98. doi: 10.1371/journal.pone.0000098.

  PMID: 17183730 DERIVED

MeSH Terms

Interventions

Hydralazine

Intervention Hierarchy (Ancestors)

Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Claudia Arce, MD

  Division of Clinical Research, IInstituto Nacional de Cancerologia, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 3, 2006
• Study Start: June 1, 2005
• Study Completion: August 1, 2006
• Last Updated: November 3, 2006

Record last verified: 2006-11

Locations

ME (1)