Trials / Completed
CompletedNCT00004149
Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Albert Einstein College of Medicine · Academic / Other
- Sex
- Male
- Age
- 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | arsenic trioxide |
Timeline
- Start date
- 1999-09-01
- Primary completion
- 2003-08-01
- Completion
- 2003-08-01
- First posted
- 2003-01-27
- Last updated
- 2018-08-17
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00004149. Inclusion in this directory is not an endorsement.