A Research Study for Patients With Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-07

Study Completion Date

2006-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the activity of romidepsin (depsipeptide,FK228) in patients with metastatic prostate cancer who have developed a rising prostate specific antigen (PSA) while undergoing hormonal therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00005848

Prostate Cancer

COMPLETED PHASE2

Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence

NCT00003858

Prostate Cancer

WITHDRAWN PHASE2

Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients

NCT02091531

Metastatic Castration-Resistant Prostate Cancer

COMPLETED PHASE2

Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer

NCT00005096

Prostate Cancer

COMPLETED PHASE2

Fulvestrant in Treating Patients With Advanced Prostate Cancer

NCT00244998

Prostate Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Metastases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Romidepsin

13 mg/m\^2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Group Type EXPERIMENTAL

Romidepsin

Intervention Type DRUG

13 mg/m2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Romidepsin

13 mg/m2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Istodax depsipeptide FK 228

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males ≥18 years;
* Written informed consent/authorization;
* Histological or cytological confirmation of metastatic prostate cancer with documented progression on hormonal therapy (objective progressive disease \[PD\], new bone lesions, or stable soft tissue or bone lesions with PSA increase);
* Patients must have either measurable disease or bone metastasis. Patients with measurable disease are preferred;
* Rising PSA, with a minimum study entry PSA of ≥5 ng/mL;
* Karnofsky performance status of ≥80%;
* Life expectancy of \>12 weeks;
* For patients treated with anti-androgens, elevation of PSA must be demonstrated after cessation of anti-androgen treatment;
* Three lines of hormonal therapy are permitted prior to study entry (anti-androgen withdrawal is not considered as a second hormonal treatment);
* Serum testosterone level of \<50 ng/mL in patients without surgical castration;
* Patients must have serum potassium levels \>4.0 mEq/L and serum magnesium levels \>2.0 mg/dL.

Exclusion Criteria

* Concomitant use of any anti-cancer therapy, except for continued use of luteinizing hormone-releasing hormone (LHRH) agonists or antiandrogens, or bisphosphonates or steroids initiated at least 4 weeks prior to study entry;
* Concomitant use of any investigational agent, including PC-SPES;
* Use of any investigational agent within 4 weeks of study entry;
* Concomitant use of warfarin (due to a potential drug-to-drug interaction with depsipeptide);
* Major surgery within 2 weeks of study entry;
* Prior treatment with chemotherapy;
* Patients with known cardiac abnormalities such as:
* Congenital long QT syndrome;
* QTc interval \> 480 milliseconds;
* Patients who have had a myocardial infarction within 12 months of study entry;
* Patients who have a history of coronary artery disease (CAD) e.g., angina Canadian Class II IV (see Appendix K). In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
* Patients with an ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
* Patients with congestive heart failure that meets NYHA Class II to IV (see Appendix J) definitions and/or ejection fraction \<40% by MUGA scan or \<50% by echocardiogram and/or magnetic resonance imaging (MRI);
* Patients with a history of sustained VT, VF, Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
* Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above);
* Patients with uncontrolled hypertension i.e., ≥160/95;
* Patients with any cardiac arrhythmia requiring anti-arrhythmic medication;
* Concomitant use of medications which may cause a prolongation of QT/QTc (see Appendix D) interval;
* Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4 (see Appendix E);
* Clinically significant active infection;
* Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
* Previous extensive radiotherapy involving 30% of bone marrow (e.g., whole of pelvis, half of spine);
* Clinical or radiological imaging evidence of brain metastasis (computed tomography \[CT\] or MRI scans are required only if brain metastasis is suspected clinically);
* Inadequate bone marrow or other organ function, as evidenced by:

* hemoglobin \<9.0 g/dL (transfusions and/or erythropoietin are permitted);
* absolute neutrophil count (ANC) ≤1.5 x 109 cells/L;
* platelet count \<100 x 109 cells/L;
* total bilirubin \>1.25 x upper limit of normal (ULN) for institution or \>2.0 x ULN in the presence of demonstrable liver metastases;
* aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) \>2.0 x ULN or \>5.0 x ULN in the presence of demonstrable liver metastases;
* serum creatinine \>2 mg/dL;
* Serum potassium levels \< 4.0 mEq/L and serum magnesium levels \<2.0 mg/dL;
* Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively); or
* Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No