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Doxercalciferol in Recurrent Pediatric Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511017
Recruitment Status : Terminated (Slow accrual.)
First Posted : August 3, 2007
Last Update Posted : July 31, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Drug: Doxercalciferol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Doxercalciferol in Recurrent Pediatric Solid Tumors
Study Start Date : August 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Doxercalciferol Drug: Doxercalciferol
.05 mcg/kg by mouth daily x 28 Days

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Continual reassessment method during 28 day cycles, weekly visits for first cycle and monthly for each additional cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 to less than or equal to grade 1 from the acute toxic effects of prior therapy, to meet eligibility criteria
  8. Adequate bone marrow function defined as peripheral absolute neutrophil count (ANC) equal or more than 500/mm^3, Hemoglobin equal or more than 8g/dl, Platelets equal or more than 20,000/mm^3
  9. Adequate renal function defined as serum creatinine <1.5 X upper limit of normal (ULN) or age adjusted creatinine clearance of >70ml/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 per institutional guidelines.
  12. Urine calcium level must be </= to the upper limit of normal value per institutional guidelines
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511017

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Peter E. Zage, MD, PhD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00511017    
Other Study ID Numbers: 2006-0423
First Posted: August 3, 2007    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Pediatric Cancer
Recurrent Pediatric Solid Tumors
Vitamin D
Additional relevant MeSH terms:
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1 alpha-hydroxyergocalciferol
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents