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

NCT ID: NCT00670046

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-07-31

Brief 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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (standard of care)

Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.

Group Type: OTHER

standard of care follow-up

Intervention Type: OTHER

participant follow the standard of care for patient with metastatic prostate cancer

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.

Group Type: EXPERIMENTAL

valproic acid

Intervention Type: DRUG

given orally

Interventions

valproic acid

given orally

Intervention Type: DRUG

standard of care follow-up

participant follow the standard of care for patient with metastatic prostate cancer

Intervention Type: OTHER

Other Intervention Names

VPA

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Rodriguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000595004

Identifier Type: -

Identifier Source: secondary_id

NA_00010227

Identifier Type: OTHER

Identifier Source: secondary_id

J07122

Identifier Type: -

Identifier Source: org_study_id