Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.

Detailed Description
-----------------
OBJECTIVES: Determine the efficacy of arsenic trioxide in patients with metastatic stage IVA or IVB hormone-refractory prostate cancer. Determine the toxicity of this drug in this patient population. Assess, in a preliminary manner, the effect of this drug on pain control in these patients. Assess the potential value of serial quantitative prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA) mRNA determinations in RNA from peripheral blood mononuclear cells as surrogate markers of disease response in patients treated with this drug. Assess the pharmacokinetics and pharmacodynamics of this drug in these patients. Assess the feasibility of using pretreatment bone marrow evaluation of PSA and PMSA mRNA levels and pi class glutathione S-transferase expression (i.e., eliminate glutathione levels) as potential correlates of disease response in patients treated with this drug. OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-5 and 8-12 for one course. Treatment continues as biweekly infusions for at least 14 additional weeks in the absence of disease progression, unacceptable toxicity, or excessive increase in serum prostate-specific antigen. Pain is assessed at baseline and then before each biweekly treatment. PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-24 months.

Official Title
-----------------
A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: arsenic trioxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: Diagnosis of stage IVA or IVB hormone-refractory prostate cancer Obstructive uropathy and/or hydronephrosis allowed if adequate renal function and urinary drainage WBC at least 2,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Bilirubin less than 2 mg/dL Exclusion Criteria: No significant active infectious disease No grade 2 or greater peripheral neuropathy No other debilitating acute or chronic co-morbid medical, neurological, or psychiatric condition that would preclude study compliance No concurrent amphotericin B or other agent that prevents restoration of potassium or magnesium to normal levels and/or correction of QT interval to under 500 milliseconds

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: arsenic trioxide|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV prostate cancer, recurrent prostate cancer