Doxercalciferol in Recurrent Pediatric Solid Tumors
This study has been terminated.
(Slow accrual.)
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00511017
First received: August 2, 2007
Last updated: July 27, 2012
Last verified: July 2012
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
- Maximum Tolerated Dose (MTD) [ Time Frame: Continual reassessment method during 28 day cycles, weekly visits for first cycle and monthly for each additional cycle ] [ Designated as safety issue: Yes ]
| Enrollment: | 1 |
| Study Start Date: | August 2007 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Doxercalciferol |
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 |
Criteria
Inclusion Criteria:
- Written and voluntary consent obtained from the patient or their legal guardians.
- Patient must be greater than 2 and less than 26 years old at time of study entry or at time of initial diagnosis
- Patient must have had histologic verification of a solid malignancy at initial diagnosis (excluding brain stem tumors and visual pathway gliomas)
- 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
- Must start protocol therapy within two weeks of disease evaluation and determination of eligibility.
- Performance status of >20% on Lansky play scale for subjects <10 years of age, >20% on Karnofsky score for subjects >= 10 years of age
- 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
- 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
- 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
- Adequate liver function defined as total bilirubin <1.5 X upper limit of normal (ULN) and AST <2 X upper limit of normal (ULN)
- Serum calcium, phosphorus, or PTH levels must be </= to the upper limit of normal age adjusted values per institutional guidelines.
- Urine calcium level must be </= to the upper limit of normal value per institutional guidelines
- 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:
- Any past history of urine calcium stones, idiopathic hypercalcemia, hereditary bone disease, or hypercalciuria in the subject
- Concurrent Medications: Patients currently taking digitalis or thiazides are ineligible
- 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.
- 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
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Peter E. Zage, MD, PhD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00511017 History of Changes |
| Other Study ID Numbers: | 2006-0423 |
| Study First Received: | August 2, 2007 |
| Last Updated: | July 27, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Neoplasms 1 alpha-hydroxyergocalciferol Ergocalciferols Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013