Completed

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

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What is being tested

arsenic trioxide

Drug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Until 120 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1999
See protocol details

Summary

Principal SponsorAlbert Einstein College of Medicine
Last updated: August 17, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004149
Principal SponsorAlbert Einstein College of Medicine
Last updated: August 17, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

37 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Until 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

4 exclusion criteria prevent from participating
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
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 significant active infectious disease

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Mount Sinai Medical Center, NY

New York, United StatesOpen Mount Sinai Medical Center, NY in Google Maps

Jacobi Medical Center

The Bronx, United States

Albert Einstein Clinical Cancer Center

The Bronx, United States
Completed3 Study Centers