Status:
COMPLETED
Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Neoplasm
Diarrhea
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to estimate the maximum tolerated dose of irinotecan with the use of cefpodoxime for pediatric solid tumor patients.
Detailed Description
This is a phase I study with the exploratory investigation of at least four dosage levels (20, 30, 45, 60) to define the tolerable dose for phase II studies. Primary consideration will be given to det...
Eligibility Criteria
Inclusion
- Subjects under 21 years of age at the time of initial diagnosis
- Recurrent solid tumors that have shown to be unresponsive to conventional treatment for their disease, or subjects with newly diagnosed tumors for whom no conventional treatment is available
- Histologic verification of solid tumor malignancy at original diagnosis
- Adequate performance status
- Neurologic deficits in subjects with central nervous system (CNS) tumors must have been relatively stable for a minimum of 2 weeks prior to study entry
- Subjects must have recovered from the toxic effects of all prior chemotherapy before entering the study
- Adequate bone marrow, renal and hepatic function
Exclusion
- No active infection at time of protocol entry, and should not be receiving antibiotics other than P. carinii pneumonia prophylaxis.
- Patients must not be pregnant or lactating.
- Patients must not be taking an enzyme-inducing anticonvulsant (e.g., phenobarbital, phenytoin, or carbamazepine), rifampin, or St. John's Wort. Dexamethasone is not to be used as an antiemetic.
- Patients must not have had any previous allergic reactions to penicillin or cephalosporins.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00143533
Start Date
September 1 2003
End Date
June 1 2011
Last Update
April 26 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105