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

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ClinicalTrials.gov Identifier: NCT00004149
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 17, 2018
National Cancer Institute (NCI)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: arsenic trioxide Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer
Actual Study Start Date : September 1999
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004149

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United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10467
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
Sponsors and Collaborators
Albert Einstein College of Medicine
National Cancer Institute (NCI)
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Study Chair: Robert E. Gallagher, MD Albert Einstein College of Medicine
Publications of Results:
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.

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ClinicalTrials.gov Identifier: NCT00004149    
Other Study ID Numbers: CDR0000067382
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Keywords provided by Albert Einstein College of Medicine:
stage IV prostate cancer
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Arsenic Trioxide
Antineoplastic Agents