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

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 weekly
    Irinotecan was administered over 90 min weekly 4x, every 6 weeks.

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's HospitalHoustonTexas77030-

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