Clinical trial NCT00004149: Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
Official title: A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer
recurrent prostate cancer
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 37
Sex: MALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Albert Einstein Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center, NY
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Robert E. Gallagher, MD
role: STUDY_CHAIR
References:
citation: 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.