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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: National Institutes of Health (NIH)
• Treatments: Camptothecin; Cefpodoxime; Cefpodoxime proxetil; Irinotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.