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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy  Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
For Condition: stage 4 prostate cancer,recurrent prostate cancer
Status: Recruiting
Sponsor(s): Albert Einstein Cancer Research Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage IVA or IVB hormone-refractory prostate cancer - Evidence of metastatic disease by physical exam, bone scan, abdominal or pelvic CT scan, or chest X-ray - Must have failed at least 2 prior hormonal therapy regimens (e.g., luteinizing hormone-releasing hormone [LHRH] agonist plus antiandrogen and antiandrogen withdrawal) - Must have 2 successive increases in serum prostate-specific antigen (PSA) levels to at least 10 ng/mL measured at least 2 weeks apart - Must have castrate testosterone levels (no greater than 50 ng/dL) due to prior orchiectomy or continuing LHRH agonist therapy - Obstructive uropathy and/or hydronephrosis allowed if adequate renal function and urinary drainage PATIENT CHARACTERISTICS: Age: - Any age Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - 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 Hepatic: - Bilirubin less than 2 mg/dL - Transaminases less than 2.5 times upper limit of normal Renal: - See Disease Characteristics - Creatinine less than 2 mg/dL - Potassium between 4.0 and 5.5 mEq/L OR - Magnesium between 1.5 and 2.5 mEq/L Cardiovascular: - No second-degree heart block without permanent pacemaker - QT interval under 500 milliseconds Other: - 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for suramin) and recovered Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior antiandrogen therapy (6 weeks for bicalutamide) (if PSA is increased from baseline) - At least 2 weeks since prior corticosteroid therapy and recovered Radiotherapy: - At least 2 weeks since prior radiotherapy (4 weeks for strontium chloride Sr 90) and recovered Surgery: - See Disease Characteristics - Recovered from prior surgery Other: - Recovered from acute toxicity of prior therapy - At least 3 weeks since prior bisphosphonates - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertGallagher, Study Chair, Albert Einstein Cancer Research Center
Jacobi Medical Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Adrian Langleben 718-918-5684
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Anna Ferrari 212-241-0481
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10467
United States
Recruiting Andreas Kaubisch 718-920-4826
Additional Information:
Study ID Numbers: CDR0000067382; AECM-1199908270,NCI-T99-0077,AECM-CCRC-9929
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004149
Other Stage 4 Prostate Cancer Studies:
1. Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
2. Rapid Hormone Cycling With Testosterone and Leuprolide Combined With Docetaxel in Treating Patients With Recurrent or Metastatic Adenocarcinoma (Cancer) of the Prostate
3. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
4. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
5. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
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