Study of Irinotecan on a Weekly Schedule in Children
Part of paid clinical trials in Houston, Texas.
- Sponsor
- Baylor College of Medicine
- Study ID
- NCT00062842
- Phase
- PHASE1
- Status
- Completed
Conditions
- Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 21 Years
- Healthy Volunteers
- Not accepted
Interventions
- Irinotecan — DRUG
Study Details
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.
Key Dates
- Start date
- Sep 9, 1998
- Status verified
- Mar 2020
- Primary completion
- May 31, 2005
- Completion
- Sep 12, 2006
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Irinotecan weeklyIrinotecan was administered over 90 min weekly 4x, every 6 weeks.
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | - |
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