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Doxercalciferol in Recurrent Pediatric Solid Tumors
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
First Received: August 2, 2007   Last Updated: December 29, 2008   History of Changes
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:

  • To determine the maximum tolerated dose (MTD) and recommended phase II dose of doxercalciferol in pediatric patients with recurrent or refractory solid tumors.

Secondary Objectives:

  • To determine the safety and tolerability, dose-limiting toxicity, and other toxicities of doxercalciferol in these patients.
  • To determine the antitumor efficacy of doxercalciferol within the confines of a phase I study.
  • To assess the pharmacodynamics of Doxercalciferol via measurement of serum parathyroid hormone (PTH), calcium, phosphorus, and creatinine levels and urine calcium levels in response to doxercalciferol treatment.
  • To collect and store neuroblastoma and retinoblastoma tumor or bone marrow samples, when available, in a research tissue bank.

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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To study the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To study the effect of the study drug on the blood levels of calcium and vitamin D. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

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
Criteria

Inclusion Criteria:

  1. Written and voluntary consent obtained from the patient or their legal guardians
  2. Patient must be greater than 2 and less than 26 years old at time of study entry or at time of initial diagnosis
  3. Patient must have had histologic verification of a solid malignancy at initial diagnosis (excluding brain stem tumors and visual pathway gliomas)
  4. Patient must have recurrent measurable or evaluable disease after therapy or refractory to conventional therapy with presence of disease confirmed by standard imaging or biopsy
  5. Must start protocol therapy within two weeks of disease evaluation and determination of eligibility
  6. Performance status of > 20% on Lansky play scale for subjects < 10 years of age, > 20% on Karnofsky score for subjects >= 10 years of age
  7. Patient must have fully recovered from acute toxic effects of prior therapy, to meet eligibility criteria
  8. Adequate bone marrow function defined as peripheral absolute neutrophil count (ANC) > 500/mm^3, hemoglobin > 8 g/dl, platelets > 50,000/mm^3
  9. Adequate renal function defined as serum creatinine < 1.5 X upper limit of normal (ULN) or age adjusted creatinine clearance of > 70 ml/min/1.73m^2
  10. Adequate liver function defined as total bilirubin < 1.5 X upper limit of normal (ULN) and AST < 2 X upper limit of normal (ULN)
  11. Serum calcium, phosphorus, or PTH levels must be </= to the upper limit of normal age adjusted values
  12. Urine calcium level must be </= to the upper limit of normal value
  13. Women of childbearing potential must have a negative serum or urine pregnancy test and not be breastfeeding prior to study therapy. Women of childbearing potential must be using an adequate form of contraception to avoid pregnancy during therapy and for at least 4 weeks after the end of study therapy in such a manner that the risk of pregnancy is minimized (Women of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization)

Exclusion Criteria:

  1. Any past history of urine calcium stones, idiopathic hypercalcemia, hereditary bone disease, or hypercalciuria in the subject
  2. Concurrent Medications: Patients currently taking digitalis or thiazides are ineligible
  3. Concurrent Medications: Oral calcium and vitamin D supplements and all homeopathic medications must be discontinued 2 weeks prior to study entry and while on study therapy
  4. Use of other anti-tumor therapy, including but not limited to chemotherapy, radiation therapy, immunotherapy, other investigational agents or other biologic therapy, during study therapy, with the exception of palliative radiation therapy to non-index lesions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511017

Contacts
Contact: Peter E. Zage, MD, PhD 713-792-6620

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Peter E. Zage, MD, PhD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Peter E. Zage, MD, PhD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Doxercalciferol
Pediatric Cancer
Recurrent Pediatric Solid Tumors
Calcium
Vitamin D

Study placed in the following topic categories:
Calcium, Dietary
Vitamin D
1 alpha-hydroxyergocalciferol
Vitamin D2
Ergocalciferol
Vitamins
Ergocalciferols
Bone Density Conservation Agents
Trace Elements
Calciferol
Micronutrients
Recurrence

Additional relevant MeSH terms:
1 alpha-hydroxyergocalciferol
Growth Substances
Vitamins
Physiological Effects of Drugs
Ergocalciferols
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009