ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00628732
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : January 28, 2009
Sponsor:
Collaborators:
Metabolic Solutions Inc.
Simmons Cancer Center
Information provided by:
Children's Medical Center Dallas

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. 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Cyclophosphamide and Topotecan Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors
Study Start Date : January 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Cyclophosphamide and Topotecan
Two courses of cyclophosphamide at 50 mg/m2/dose and topotecan 0.8 mg/m2/dose by mouth every morning for 14 days each.
Other Name: Cytoxan and Hycamptin



Primary Outcome Measures :
  1. Radiographic imaging [ Time Frame: Every 2 cycles ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628732


Locations
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Children's Medical Center Dallas
Metabolic Solutions Inc.
Simmons Cancer Center
Investigators
Principal Investigator: Daniel C Bowers, MD UT Southwestern Medical Center of Dallas

Responsible Party: Daniel C. Bowers M.D./ Associate Professor of Pediatrics, UT Southwestern Medical Center of Dallas
ClinicalTrials.gov Identifier: NCT00628732     History of Changes
Other Study ID Numbers: 012005004
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009

Keywords provided by Children's Medical Center Dallas:
Cyclophosphamide
Topotecan
Phase II
Children
Relapsed solid tumors

Additional relevant MeSH terms:
Cyclophosphamide
Topotecan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors