Clincosm LogoSign in Get a demo

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

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00004149
Collaborator
National Cancer Institute (NCI) (NIH)
37
Enrollment
3
Locations
47
Actual Duration (Months)
12.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: arsenic trioxide
 Phase 2

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 Design

Study Type:
Interventional
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 :
Sep 1, 1999
Actual Primary Completion Date :
Aug 1, 2003
Actual Study Completion Date :
Aug 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 120 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jacobi Medical Center Bronx New York United States 10461
    2 Albert Einstein Clinical Cancer Center Bronx New York United States 10467
    3 Mount Sinai Medical Center, NY New York New York United States 10029

    Sponsors and Collaborators

    • Albert Einstein College of Medicine
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Robert E. Gallagher, MD, Albert Einstein College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004149
    Other Study ID Numbers:
    • CDR0000067382
    • AECM-1199908270
    • NCI-T99-0077
    • AECM-CCRC-9929
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Aug 17, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by , ,
    stage IV prostate cancer
    recurrent prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Arsenic Trioxide

    Study Results

    No Results Posted as of Aug 17, 2018