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Trial record 94 of 182 for:    ERYTHROMYCIN

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

Tracking Information
First Submitted Date  ICMJE February 25, 2008
First Posted Date  ICMJE March 5, 2008
Last Update Posted Date January 28, 2009
Study Start Date  ICMJE January 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
Radiographic imaging [ Time Frame: Every 2 cycles ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00628732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pharmacokinetic Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors
Official Title  ICMJE A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Cyclophosphamide and Topotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 25, 2008)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00628732
Other Study ID Numbers  ICMJE 012005004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel C. Bowers M.D./ Associate Professor of Pediatrics, UT Southwestern Medical Center of Dallas
Study Sponsor  ICMJE Children's Medical Center Dallas
Collaborators  ICMJE
  • Metabolic Solutions Inc.
  • Simmons Cancer Center
Investigators  ICMJE
Principal Investigator: Daniel C Bowers, MD UT Southwestern Medical Center of Dallas
PRS Account Children's Medical Center Dallas
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP