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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00511017 |
Purpose
The goal of this clinical research study is to find the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The safety of this drug will also be studied. Another goal is to measure the effect of the study drug on the blood levels of calcium and vitamin D.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: Doxercalciferol |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study of Doxercalciferol in Recurrent Pediatric Solid Tumors |
| Estimated Enrollment: | 24 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Doxercalciferol: Experimental |
Drug: Doxercalciferol
.05 mcg/kg by mouth daily x 28 Days
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 2 Years to 26 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Peter E. Zage, MD, PhD | 713-792-6620 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Peter E. Zage, MD, PhD | |
| Principal Investigator: | Peter E. Zage, MD, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Peter E. Zage, MD, PhD/Assistant Professor ) |
| Study ID Numbers: | 2006-0423 |
| Study First Received: | August 2, 2007 |
| Last Updated: | September 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00511017 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Solid Tumors Doxercalciferol Pediatric Cancer |
Recurrent Pediatric Solid Tumors Calcium Vitamin D |
|
Neoplasms 1 alpha-hydroxyergocalciferol Growth Substances Vitamins Physiological Effects of Drugs |
Ergocalciferols Bone Density Conservation Agents Micronutrients Pharmacologic Actions |