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Brief Title: Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Official Title: Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer
Study ID: NCT00524589
Brief Summary: RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy . PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.
Detailed Description: OBJECTIVES: * To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone. * To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients. OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and on days 2 and 3 to assess VDR and CYP24 expression in peripheral blood mononuclear cells.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Roswell Park Cancer Institute, Buffalo, New York, United States
Name: Donald L. Trump, MD
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR