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

NCT00670046 | Terminated Phase 2 Results FDA Drug

• 4 other identifiers: J07122P30CA068485CDR0000595004NA_00010227
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time

  Number of participants exhibiting an increase in observed or predicted prostate-specific antigen (PSA) doubling time after initiation of the study. Blood was drawn monthly during study period (1 year), serum PSA was measured \& PSADT calculated. A doubling time of \> 10 month is defined as complete response (3. Secondary Outcome) and this criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper. Any increase in PSADT is defined as partial response (4. Secondary Outcome).

  1 year

Secondary Outcomes (4)

• Duration of PSA Response as Assessed by PSA Doubling Time (PSADT)

  pre-study, mid-study, end of study (up to 1 year)

• Number of Participants Who Achieve a Complete Response

  one year

• Number of Participants Who Achieve a Partial Response

  one year

• Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score

  at time of enrollment, mid-study, end of study (up to 1 year)

Study Arms (2)

Arm I (standard of care)

OTHER

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

Other: standard of care follow-up

Arm II (valproic acid)

EXPERIMENTAL

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

Interventions

valproic acid DRUG

given orally

Also known as: VPA

Arm II (valproic acid)

standard of care follow-up OTHER

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

Arm I (standard of care)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Limitations and Caveats

The study was designed to have power with 15 patients in each arm. The study was closed before we reached the target as the PI changed institution.

Results Point of Contact

• Title: Ron Rodriguez, MD, PhD
• Organization: UTHSCSA

rodriguezr32@uthscsa.edu

2105675643

Study Officials

• Ronald Rodriguez, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 1, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 28, 2018
• Results First Posted: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)