Status:
COMPLETED
A Pharmacokinetic Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors
Lead Sponsor:
Children's Medical Center Dallas
Collaborating Sponsors:
Metabolic Solutions Inc.
Simmons Cancer Center
Conditions:
Solid Tumors
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
The purposes of this study include: * Determination of the change in clearance of topotecan and topotecan lactone between day 1 and day 14 for patients receiving treatment with p.o. topotecan and p.o...
Detailed Description
Upon obtaining informed consent, patients will begin two courses of oral cyclophosphamide and topotecan x 14 days. During the first of two courses, patients will perform the 14C-Erythromycin Breath Te...
Eligibility Criteria
Inclusion
- Patients must be less than 22 years of age inclusive
- Tumor histologies: medulloblastoma/PNET, neuroblastoma, sarcomas, and other pediatric solid tumors for which there is no known effective therapy.
- Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria.
- Patients must have a performance status of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients \<= 16 years of age.
- Patients must have a life expectancy of \>= 8 weeks.
- Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- Patients must not be taking the following medications: growth factors, steroids, and CYP3A4 inducers or inhibitors.
- Patients must have adequate bone marrow, renal, liver function, pulmonary, or central nervous system function.
- Must be able and willing to participate in all study procedures, including the ERMBT and pharmacokinetic studies.
- All patients and/or their parents or legal guardians must sign a written informed consent. (11) All institutional, FDA, and NCI requirements for human studies must be met.
Exclusion
- Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Patients with an uncontrolled infection.
- Allergy to erythromycin
- Patients who have previously received either cyclophosphamide or topotecan are eligible for this study.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00628732
Start Date
January 1 2005
End Date
February 1 2007
Last Update
January 28 2009
Active Locations (1)
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1
Children's Medical Center Dallas
Dallas, Texas, United States, 75235