Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004149|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 17, 2018
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|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
|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|
|Study Chair:||Robert E. Gallagher, MD||Albert Einstein College of Medicine, Inc.|