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

Prostate Cancer Clinical Trial

Official title:

A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004149
• Other study ID #: CDR0000067382
• Secondary ID: AECM-1199908270N
• Status: Completed
• Phase: Phase 2
• Start date: September 1999
• Est. completion date: August 2003

Study information

• Verified date: August 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 120 Years

Eligibility

Eligibility Criteria:

• Diagnosis of stage IVA or IVB hormone-refractory prostate cancer

• Obstructive uropathy and/or hydronephrosis allowed if adequate renal function and urinary drainage

• WBC at least 2,500/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL

• Bilirubin less than 2 mg/dL

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	Jacobi Medical Center	Bronx	New York
United States	Mount Sinai Medical Center, NY	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gallagher RE, Ferrari A, Kaubisch A, et al.: Arsenic trioxide (ATO) in metastatic hormone-refractory prostate cancer (HRPC): results of phase II trial T99-0077. [Abstract] J Clin Oncol 22 (Suppl 14): A-4638, 2004.