Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: valproic acid (Drug); standard follow-up care (Procedure)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sidney Kimmel Comprehensive Cancer Center Official(s) and/or principal investigator(s): Ronald Rodriguez, MD, PhD, Principal Investigator, Affiliation: Sidney Kimmel Comprehensive Cancer Center
Summary
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.
Clinical Details
Official title: Randomized, Controlled Phase II Study of Valproic Acid in Patients With Non-metastatic Biochemical Progression of Prostate Cancer
Study design: Allocation: Randomized, Primary Purpose: Treatment
Primary outcome: Percentage of patients exhibiting observed or predicted prostate-specific antigen (PSA) doubling time > 10 months after initiation of the study
Secondary outcome: Duration of PSA responsePercentage of patients who achieve a complete response Percentage of patients who achieve a partial response Self-perceived functionality, psychosocial well-being, and quality of life
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
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Male.
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
Locations and Contacts
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States; Recruiting Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce, Phone: 410-955-8804, Email: jhcccro@jhmi.edu
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 2008
Last updated: February 18, 2011
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