Study of Irinotecan on a Weekly Schedule in Children

NCT00062842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-03-04

No results posted yet for this study

Summary

The medicine being offered in this study is called Irinotecan. Irinotecan has been effective against many animal cancers. It has been given to both adults and children. We are now attempting to determine how much of the drug can be given to children when Irinotecan is given weekly for four weeks in a row every 6 weeks and the toxicities (bad side effects) that occur when irinotecan is administered on this schedule.

The purposes of this study are to:

1. To determine the highest dose of Irinotecan that can safely be given to children whose cancer no longer responds to standard treatment.
2. To determine the toxicities of Irinotecan.
3. To determine what studies (laboratory or x-rays) need to be done to evaluate the toxicities of this drug.
4. To determine if irinotecan is beneficial to the patient.
5. To understand how the drug Irinotecan works in the body.

Conditions

Interventions

DRUG

Irinotecan

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Susan Blaney, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-09-09
Primary Completion
2005-05-31
Completion
2006-09-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00062842 on ClinicalTrials.gov