A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors
Information source: Children's Medical Center Dallas
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Solid Tumors
Intervention: Cyclophosphamide and Topotecan (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Children's Medical Center Dallas Official(s) and/or principal investigator(s):
Daniel C Bowers, MD, Principal Investigator, Affiliation: UT Southwestern Medical Center of Dallas
Overall contact:
Jennifer L Evans, B.A., B.S., Phone: 214.456.8138, Email: jennifer.evans@childrens.com
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.
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.
Clinical Details
Official title: A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Radiographic imaging
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 Test and have topotecan pharmacokinetics performed on day 1 and 14.
The subjects will also have various medical tests and procedures performed that are part of
regular cancer care which include: Medical history and physical examination to be done
weekly, blood tests to be done weekly, heart and kidney function tests, various scans to be
done after two courses of treatment, and a pregnancy test for females of childbearing age to
be done prior to starting treatment.
Patients may continue to receive additional courses of oral cyclophosphamide and topotecan
provided that they do not experience tumor progression or intolerable side effects.
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients must be less than 22 years of age inclusive
2. Tumor histologies: medulloblastoma/PNET, neuroblastoma, sarcomas, and other pediatric
solid tumors for which there is no known effective therapy.
3. Patients must have measurable disease, documented by clinical, radiographic, or
histologic criteria.
4. 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.
5. Patients must have a life expectancy of >= 8 weeks.
6. Prior Therapy: Patients must have fully recovered from the acute toxic effects of all
prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
7. Patients must not be taking the following medications: growth factors, steroids, and
CYP3A4 inducers or inhibitors.
8. Patients must have adequate bone marrow, renal, liver function, pulmonary, or central
nervous system function.
9. Must be able and willing to participate in all study procedures, including the ERMBT
and pharmacokinetic studies.
10. 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 Criteria:
1. Males or females of reproductive potential may not participate unless they have agreed
to use an effective contraceptive method.
2. Patients with an uncontrolled infection.
3. Allergy to erythromycin
4. Patients who have previously received either cyclophosphamide or topotecan are
eligible for this study.
Locations and Contacts
Jennifer L Evans, B.A., B.S., Phone: 214.456.8138, Email: jennifer.evans@childrens.com
Children's Medical Center Dallas, Dallas, Texas 75235, United States; Recruiting
Additional Information
Starting date: January 2005
Ending date: February 2010
Last updated: February 25, 2008
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