The histone deacetylase inhibitor (HDAC) valproic acid as second line treatment for hormone refractory metastatic prostate cancer. A phase II. study. - HDAC-VA

Phase 1

• Conditions: hormone refractory metastatic prostate cancer

• Registration Number: EUCTR2006-003554-15-SK
• Lead Sponsor: ational Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

1.signed written informed consent
2.men aged 18 years or older
3.histologically proven metastatic hormone refractory prostatic adenocarcinoma, with progression after standard 1st line chemotherapy (only docetaxel+prednisone). The progression is defined: progression according RECIST criteria or evidence of PSA progression. Minimum evidence of progression is a 25% increase over a reference value of PSA (20ng/mL), provided that the increase is > 5 ng/mL. The first increase in PSA should occur at a minimum of one week from the reference value. This increase should then be confirmed by a second increase in PSA at least 1 week later (Bubley, 1999).
4.patients with measurable or non-measurable disease as defined in the RECIST criteria: At least one site of disease must be unidimensionally measurable as follows:
X-ray, physical exam > 20 mm } N.B. Most hospitals have spiral CT scanning
Spiral CT scan > 10 mm } equipment – check with your radiology department.
Non-spiral CT scan> 20 mm }
All radiology studies must be performed within 28 days prior to registration
5.ECOG PS 0 – 1 at study entry
6.at least 4 weeks must have elapsed since the last surgery, radiotherapy and/or chemotherapy before study entry
7.complete recovery from prior surgery, and/or reduction of all adverse events to grade 1 from previous systemic therapy or radiotherapy
8.no concurent treatment with experimental drugs was allowed.
9.no concurrent chemotherapy. Corticosteroids and bisphophonates are permitted if they were admistered more than 2 months before study entry in the same dose and route of application.
10.patients with surgical castration or patients without surgical castration must have a serum testosterone level less than 50ng/ml before study entry and to continue on LHRH agonist therapy
11.adequate renal function defined as creatinine clearance > 60ml/min
12.adequate liver function defined by normal total bilirubin level and ALT, AST < 2,0 ULN
13.adequate hematologic function defined by ANC > 1500/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl.
14.normal blood coagulation tests: INR, fibrinogen, PTT, bleeding time
15.serum albumin level > 34g/l
16.life expectancy more than 3 months
17. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.inability to absorb medication e.g. malabsorption syndrome
2.hepatic porphyria
3.acute or chronic hepatitis (positivity HbsAg, antiHCV and/or LFT`s see also inclusion criteria)
4.hypersensitivity to valproic acid
5.personal or familial history of severe drug induced hepatitis
6.grade 3-4 infection without neutropenia
7.known CNS metastasis
8.Any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years.
9.Serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator )
10.systemic lupus erythematosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified