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A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors

Phase 2
21 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors

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.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiographic imaging

Outcome Time Frame:

Every 2 cycles

Safety Issue:


Principal Investigator

Daniel C Bowers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT Southwestern Medical Center of Dallas


United States: Institutional Review Board

Study ID:




Start Date:

January 2005

Completion Date:

February 2007

Related Keywords:

  • Solid Tumors
  • Cyclophosphamide
  • Topotecan
  • Phase II
  • Children
  • Relapsed solid tumors
  • Neoplasms



Children's Medical Center Dallas Dallas, Texas  75235