A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer
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.
Interventional
Primary Purpose: Treatment
Robert E. Gallagher, MD
Study Chair
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
CDR0000067382
NCT00004149
September 1999
Name | Location |
---|---|
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 |