MDACC Study Summary 2006-0423 (Archived)

Study Summary
No. 2006-0423:.......Pediatrics; Phase I Studies; Solid Tumors......Peter E. Zage......Pediatrics

Study Summary Title



Study Summary Number:	2006-0423

Study Title:	A Phase I Study of Doxercalciferol in Recurrent Pediatric Solid Tumors

Physician

New Patient Referral



Name:	Peter E. Zage	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6620 Contact us about clinical trials

General Information



Disease Group:	Pediatrics Phase I Studies Solid Tumors	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Weekly visits during the first cycle of treatment, then monthly until therapy completed.

Treatment Agents:	Doxercalciferol	Home Care:	Oral study medication (doxercalciferol) given daily.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	No hospital stays are anticipated


Description/ Intervention:	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.

Study Objectives / Outcomes

Proposed Research
We 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 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.

Study Status Information



Study Activation / Registration Date:	08/01/2007

IRB Review and Approval Date:	03/22/2007

Study Type:	Phase I

Recruitment Status:	Terminated

Projected Accrual:	24

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00511017
Study Information on Clinical Trials Registry (clinicaltrials.gov)