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

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00004149
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (3)

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States

Albert Einstein Clinical Cancer Center; 🇺🇸 Bronx, New York, United States

Mount Sinai Medical Center, NY; 🇺🇸 New York, New York, United States