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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00511017 |
Purpose
Proposed Research:
Investigators propose to perform a single institution dose-escalation phase I trial of doxercalciferol in pediatric patients with recurrent or refractory solid tumors to determine the maximum tolerated dose, safety and tolerability, and potential treatment efficacy.
Primary Objective:
Secondary Objectives:
| 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 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Doxercalciferol
|
Drug: Doxercalciferol
.05 mcg/kg PO 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: | December 29, 2008 |
| 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 |
|
Calcium, Dietary Vitamin D 1 alpha-hydroxyergocalciferol Vitamin D2 Ergocalciferol Vitamins |
Ergocalciferols Bone Density Conservation Agents Trace Elements Calciferol Micronutrients Recurrence |
|
1 alpha-hydroxyergocalciferol Growth Substances Vitamins Physiological Effects of Drugs |
Ergocalciferols Bone Density Conservation Agents Micronutrients Pharmacologic Actions |