ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors

NCT00132158 | Completed Phase 1

• 2 other identifiers: POCPZDIRUSIRES0181
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous (given into the vein) formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.

Conditions

Glioblastoma; Rhabdomyosarcomas; Neuroblastoma; Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• To estimate the maximum tolerated dose (MTD) of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib.

  Within the first 30 days of completion of first cycle of chemotherapy.

Study Arms (1)

1

OTHER

Drug: Irinotecan (Camptosar), Gefitinib (Iressa)

Interventions

Irinotecan (Camptosar), Gefitinib (Iressa) DRUG

See Detailed Description for treatment plan.

1

Eligibility Criteria

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

You may qualify if:

• Patient's age is less than or equal to 21 years at the time of study entry.
• Patient has a histologically or pathologically confirmed diagnosis of a recurrent solid tumor that did not respond to standard treatment or one for which there is no known therapy.
• Patient has adequate performance status, along with adequate function of the liver, kidney and bone marrow.
• Must have recovered from chemotherapy
• No active GVHD nor treatment for GVHD

You may not qualify if:

• Patient is receiving other cytotoxic or investigational drug or has evidence of another active illness
• Active diarrhea
• Active intercurrent serious or uncontrolled illness
• Pregnant or lactating
• Concomitant use of medications that may interact with study drugs
• Active infection
• Known history of life-threatening allergy or hypersensitivity to camptothecin Active interstitial lung disease

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Glioblastoma; Rhabdomyosarcoma; Neuroblastoma; Osteosarcoma

Interventions

Irinotecan; Gefitinib

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lisa M McGregor, MD, PhD

  St. Jude Children's Research Hospital

  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: SPONSOR

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Study Start: September 1, 2005
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 17, 2012

Record last verified: 2012-04

Locations

US (1)