Status and phase
Conditions
Treatments
About
The purposes of this study are to:
Full description
Calcitriol, at low doses, is approved by the FDA for use in patients with chronic renal failure. However, much higher doses of calcitriol are needed for any possible anti-cancer effect. DN-101 is a new capsule that contains 30 times the amount of calcitriol found in the currently available calcitriol capsule. In order to take an amount of calcitriol equivalent to 1 capsule of DN-101, cancer patients would need to swallow 30 pills of the approved, low dose formulation.
DN-101 is a pill containing calcitriol, a chemical related to vitamin D that is immediately active in your body. The natural vitamin D found in dairy products or in typical vitamin pills, must be chemically changed by your liver and kidney into calcitriol before it is active. High doses of calcitriol had anti-cancer effects when tested in animals. DN-101 may have anticancer effects in your kind of cancer.
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
Patients with advanced solid tumor malignancies
Patients with prostate cancer are eligible 1) if they have had a prostatectomy or radiation therapy and have a rising PSA, 2) if they have androgen sensitive prostate cancer and are on hormone therapy, or 3) if they have androgen independent prostate cancer and have failed hormone therapy
Patients with other types of malignancies will be required to have failed at least one potentially effective therapy prior to study entry
Life expectancy > 3 months
Age > 18 years
The following laboratory results:
Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment
Signed informed consent form
Exclusion Criteria
Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
Primary purpose
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Interventional model
Masking
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Data sourced from clinicaltrials.gov
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