Several studies have shown that irinotecan is one of the most effective anti-cancer drugs used in cancer of children and young adults, especially when it is given every day, for several days in a row. However, one of the most common side effects from this therapy is diarrhea, which can sometimes be severe. Because of this, researchers have not been able to increase the dose of irinotecan beyond a certain dose. Researchers want to investigate whether giving the antibiotic cefpodoxime during the time irinotecan is given, will prevent severe diarrhea and then physicians will be able to increase the dose of irinotecan beyond what has been given in the past.

In this study, to find the highest safe dose of irinotecan, investigators will treat different groups of children with different doses of irinotecan. Once a safe dose is found in one group, the next group of patients will receive a higher dose. If serious side effects occur with a certain dose, physicians will not increase the dose further. Children will receive irinotecan into the vein (IV) every day for five days in a row, followed by two days of rest. After two days of rest, each child will again receive irinotecan into the vein every day for five days, followed by nine days of rest. These two weeks of treatment, and one week of rest is considered one course (21 days). Each child will start a new course of treatment after 3 weeks. Each child will also receive the antibiotic, cefpodoxime.

Condition	Intervention	Phase
Neoplasm Diarrhea	Drug: Irinotecan, Cefpodoxime	Phase I

Further Study Details: 

Primary Outcomes: To find out if it is possible to increase the dose of the anti-cancer drug irinotecan, beyond what we have given before, if we also use an antibiotic (cefpodoxime).; To find out how the body uses irinotecan (pharmacokinetics) when it is also given with the antibiotic cefpodoxime.; To learn the effects (good and bad) of these drugs working together on your child’s type of cancer and the side effects they cause.; To find out what effect cefpodoxime has on a certain intestinal bacteria product called ß-glucuronidase.; To find out if the amount of the intestinal bacteria, which will be indirectly measured by looking at the amount of ß-glucuronidase that they produce, is related to how much and how often a patient has diarrhea.
Expected Total Enrollment:  30

Ages Eligible for Study:  up to  20 Years,  Genders Eligible for Study:  Both

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:

-

Please refer to this study by ClinicalTrials.gov identifier  NCT00143533

Carlos Rodriguez-Galindo, MD      1-866-278-5833    info@stjude.org

Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting

Study chairs or principal investigators

Carlos Rodriguez-Galindo, MD,  Principal Investigator,  St. Jude Children''''s Research Hospital   

Study ID Numbers:  CPTCEF
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00143533
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06