Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00670046
First received: April 30, 2008
Last updated: February 18, 2011
Last verified: July 2009
  Purpose

RATIONALE: Valproic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether valproic acid is more effective than observation in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well valproic acid works in treating patients with progressive, non-metastatic prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: valproic acid
Procedure: standard follow-up care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized, Controlled Phase II Study of Valproic Acid in Patients With Non-metastatic Biochemical Progression of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients exhibiting observed or predicted prostate-specific antigen (PSA) doubling time > 10 months after initiation of the study [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of PSA response [ Designated as safety issue: No ]
  • Percentage of patients who achieve a complete response [ Designated as safety issue: No ]
  • Percentage of patients who achieve a partial response [ Designated as safety issue: No ]
  • Self-perceived functionality, psychosocial well-being, and quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm I (observation)
Patients undergo observation according to standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.
Procedure: standard follow-up care
no intervention
Experimental: Arm II (valproic acid)
Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.
Drug: valproic acid
given orally

Detailed Description:

OBJECTIVES:

Primary

  • Assess whether treatment with valproic acid (a type I histone deacetylase inhibitor) can alter the kinetics of prostate-specific antigen (PSA) progression in patients with non-metastatic prostate cancer and biochemical progression.

Secondary

  • Determine the duration of PSA response.
  • Assess the percentage of patients who achieve a complete response.
  • Assess the percentage of patients who achieve a partial response.
  • Assess the quality of life of these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.

  • Arm I (observation): Patients undergo observation according to standard of care.
  • Arm II (valproic acid): Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

    • Asymptomatic, non-metastatic disease
  • Biochemical progression after definitive local therapy (radical prostatectomy)

    • Most recent prostate-specific antigen (PSA) level ≥ 1.0 ng/mL AND rising over the prior value
    • No clinical or radiological evidence of local progression
  • PSA doubling time (DT) < 10 months after local therapy (in patients who have not received prior hormone therapy)

    • At least three PSA values (each at least 4 weeks apart) are required to calculate the PSA-DT
  • No clinical or radiological evidence of metastatic disease, including bone metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Total bilirubin normal
  • AST/ALT < 2.5 times upper limit of normal
  • Creatinine ≤ 2.5 mg/dL
  • Platelet count > 125,000/mm^3
  • PT and aPTT ≤ 1.3 times above the standard reference
  • Albumin ≥ 3.5 g/dL
  • Geographically accessible and willing to participate in all stages of study treatment
  • No active second malignancy
  • No known HIV positivity
  • No active, uncontrolled infection (e.g., hepatitis A, B, or C infection)
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to valproic acid
  • No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal study treatment and follow-up
  • No history of hepatic disease or significant hepatic dysfunction
  • No history of pancreatitis
  • No history of seizure disorder or clinically treated bipolar disorder

PRIOR CONCURRENT THERAPY:

  • More than 6 months since prior hormone therapy
  • No prior valproic acid
  • At least 2 weeks since prior drugs specifically known to interact with valproic acid including, but are not limited to, aspirin, felbamate, rifampin, amitriptyline/nortriptyline, carbamazepine, clonazepam, diazepam, ethosuximide, lamotrigine, phenobarbital, primidone, phenytoin, tolbutamide, warfarin, or zidovudine
  • No concurrent systemic chemotherapy for prostate cancer
  • No other concurrent investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670046

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce    410-955-8804    jhcccro@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Ronald Rodriguez, MD, PhD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ronald Rodriguez, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00670046     History of Changes
Other Study ID Numbers: CDR0000595004, JHOC-J07122, JHOC-NA_00010227
Study First Received: April 30, 2008
Last Updated: February 18, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 20, 2014