Study of Irinotecan on a Weekly Schedule in Children

NCT00062842 | Completed Phase 1

• 1 other identifier: H6957
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Study Arms (1)

Irinotecan weekly

EXPERIMENTAL

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

Drug: Irinotecan

Interventions

Irinotecan DRUG

Also known as: Onivyde,

Irinotecan weekly

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Patients who have previously received irinotecan.
• Patients who are pregnant or lactating. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• Patients who have an uncontrolled infection.
• Patients who are receiving any other cancer chemotherapy or any other investigational agents.
• Patients who have had a BMT which included TBI or an allogeneic BMT.
• Patients with bone marrow involvement.
• Patients who are receiving anticonvulsants as outlined in stratum 3.
• Stratum 2:
• Patients who have received more than two prior multi-agent chemotherapy regimens.
• Patients who have had prior central axis radiation.
• Patients who have had bone marrow transplantation (with or without TBI).
• Patients who have had pelvic, and/or total abdominal radiation.
• Stratum 3:
• Patients must be on a stable dose of their anticonvulsant medication for a minimum of two weeks prior to study entry.
• Patients who are taking valproic acid must also be receiving another enzyme inducing anticonvulsant drug in order to be eligible for the study.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Irinotecan; irinotecan sucrosofate

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Susan Blaney, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics-Hema & Oncology

Study Record Dates

• First Submitted: June 17, 2003
• First Posted: June 18, 2003
• Study Start: September 9, 1998
• Primary Completion: May 1, 2005
• Study Completion: September 12, 2006
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

US (1)