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

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Hormones

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