Doxercalciferol in Recurrent Pediatric Solid Tumors

NCT00511017 | Terminated Phase 1

• 1 other identifier: 2006-0423
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

Solid Tumors; Doxercalciferol; Pediatric Cancer; Recurrent Pediatric Solid Tumors; Calcium; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  Continual reassessment method during 28 day cycles, weekly visits for first cycle and monthly for each additional cycle

Study Arms (1)

Doxercalciferol

EXPERIMENTAL

Drug: Doxercalciferol

Interventions

Doxercalciferol DRUG

.05 mcg/kg by mouth daily x 28 Days

Doxercalciferol

Eligibility Criteria

• Age: 2 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms

Interventions

1 alpha-hydroxyergocalciferol

Study Officials

• Peter E. Zage, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)