A Pharmacokinetic Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors

Completed · Phase 2

Conditions studied: Solid Tumors

In brief

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. cyclophosphamide x 14 days. * Determination of the correlation between the activity of CYP3A4, as measured by the 14C- Erythromycin Breath Test (ERMBT), and topotecan/topotecan lactone clearance for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days. * Determination of the response rate to oral cyclophosphamide and oral topotecan in recurrent and/or refractory pediatric solid tumors. * Obtain additional safety data for the chemotherapy regimen, p.o. topotecan and p.o. cyclophosphamide x 14 days. * Report the frequency of severe toxicities associated with the level of CYP3A4 activity, as measured by the ERMBT, for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.

Key facts

Study ID

NCT00628732

Run by

Children's Medical Center Dallas

People needed

36

Starts

2005-01-01

Expected to finish

2007-02-01

Last updated by the study team

2009-01-28

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Medical Center Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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