A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer
- 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
- 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
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
Primary Purpose: Treatment
Robert E. Gallagher, MD
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
|Mount Sinai Medical Center, NY||New York, New York 10029|
|Albert Einstein Clinical Cancer Center||Bronx, New York 10461|
|Jacobi Medical Center||Bronx, New York 10461|