Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2003-08-31

Brief Summary

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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.

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Detailed Description

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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

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Prostate Cancer

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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arsenic trioxide

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No