Valproic Acid and Bevacizumab in Patients With Advanced Cancer

NCT00530907 | Completed Phase 1

• 1 other identifier: 2005-0676
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of bevacizumab in combination with valproic acid that can be given to patients with advanced cancer that has not responded to standard treatment or where there is no standard treatment for the disease. The safety of this drug combination will also be studied.

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Valproic Acid; Depakene; Bevacizumab; Avastin; Anti-VEGF monoclonal antibody; rhuMAb-VEGF

Outcome Measures

Primary Outcomes (1)

• Highest tolerable dose of bevacizumab in combination with valproic acid

  28 day cycle

Study Arms (1)

Valproic Acid + Bevacizumab

EXPERIMENTAL

Valproic acid administered at a dose of 5.3 mg/Kg/day on days 1 - 28. Depending on the calculated dose, patients will take capsules once or twice a day per mouth. Bevacizumab administered at a dose of 2.5 mg/kg by vein every 2 weeks.

Drug: Valproic Acid; Drug: Bevacizumab

Interventions

Valproic Acid DRUG

5.3 mg/kg by mouth daily x 28 days

Also known as: Depakene

Valproic Acid + Bevacizumab

Bevacizumab DRUG

2.5 mg/kg by vein over 90 minutes every 2 weeks

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

Valproic Acid + Bevacizumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.
• ECOG performance status less than 2.
• Patients must have normal organ and marrow function as defined below: - absolute neutrophil count greater than or equal to 1,000/mcL - platelets greater than 50,000/mcL - total bilirubin less than 2 mg/dl - creatinine less than 2 mg/dl
• The effects of bevacizumab on the developing human fetus are unknown. For this reason and because valproic acid is known to be teratogenic, women of child-bearing potential and men who may impregnate a woman must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign an MD Anderson IRB approved written informed consent document.
• Both men and women of all races and ethnic groups are eligible for this trial.

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to receiving first dose of study drug or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
• Patients may not be receiving any other investigational agents for 28 days prior to first dose of drug on this study, and while pt is receiving this study drug.
• Patients whose brain mets or primary brain tumor includes symptoms that in the opinion of the principle investigator would either put the patients at unacceptable risk greater than the risk of the underlying cancer or if the treatment would unacceptably confound the analysis of the toxicity assessment.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or valproic acid .
• Major surgery within the previous four weeks.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, HTN (with 2 or more antihypertensives), unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because valproic acid is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with valproic acid and bevacizumab, breastfeeding should be discontinued if the mother is treated with these agents.
• Patient who are already on antiepileptic agents, for example; phenytoin, valproic acid, and neurontin will be excluded.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Interventions

Valproic Acid; Bevacizumab

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jennifer Wheler, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2007
• First Posted: September 18, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 8, 2015

Record last verified: 2013-11

Locations

US (1)