Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasm, Diarrhea

In brief

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.

Key facts

Study ID

NCT00143533

Run by

St. Jude Children's Research Hospital

People needed

20

Starts

2003-09-01

Expected to finish

2011-06-01

Last updated by the study team

2017-04-26

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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