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
Recruitment status was Recruiting
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
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
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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
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 May 23, 2013