Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer|
|Study Start Date:||September 1999|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004149
|United States, New York|
|Jacobi Medical Center|
|Bronx, New York, United States, 10461|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10467|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|Study Chair:||Robert E. Gallagher, MD||Albert Einstein College of Medicine of Yeshiva University|