Prostate Cancer
Conditions
Keywords
stage IV prostate cancer, recurrent prostate cancer
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.
Interventions
DRUGarsenic trioxide
Sponsors
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed