Full Text View
Tabular View
No Study Results Posted
Related Studies
Gefitinib in Treating Children With Refractory Solid Tumors
This study has been completed.
First Received: July 8, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00040781
  Purpose

RATIONALE: Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase I trial to study the effectiveness of gefitinib in treating children who have refractory solid tumors.


Condition Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: gefitinib
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study Of ZD1839 (Iressa), An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, In Children With Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of gefitinib in children with refractory solid tumors.
  • Determine the dose-limiting toxicity of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine, preliminarily, the antitumor activity of this drug in these patients.
  • Correlate the pharmacogenetic polymorphisms of this drug with pharmacokinetics and pharmacodynamics in these patients.

OUTLINE: This is a dose-escalation, multicenter study. If myelosuppression is found to be the dose-limiting toxicity, patients are stratified according to prior therapy (more than 2 multiagent chemotherapy regimens or radiotherapy to more than 20% of the bone marrow or stem cell transplantation with or without total body irradiation vs more than 2 single-agent phase I or phase II agents) and extent of disease (bone marrow involvement vs meeting none of the stratum I criteria).

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 3-45 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor at original diagnosis
  • Refractory to conventional therapy and other therapies of higher priority according to the COG Phase I/II priority list or no conventional therapy exists
  • No primary CNS tumors or known metastases to the CNS

PATIENT CHARACTERISTICS:

Age:

  • Under 22

Performance status:

  • Karnofsky 50-100% (over 10 years of age) OR
  • Lansky 50-100% (10 years of age and under)

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 50,000/mm^3 (transfusion independent)
  • Hemoglobin at least 8.0 g/dL (RBC transfusion allowed)

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT no greater than 3 times ULN
  • Albumin at least 2 g/dL

Renal:

  • Creatinine normal for age OR
  • Glomerular filtration rate at least 70 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 6 months since prior allogeneic stem cell transplantation (SCT)

    • No evidence of active graft-versus-host disease
  • At least 1 week since prior biologic agents
  • At least 1 week since prior hematopoietic growth factors
  • Recovered from prior immunotherapy

Chemotherapy:

  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered

Endocrine therapy:

  • No concurrent tamoxifen

Radiotherapy:

  • At least 2 weeks since prior local palliative (small port) radiotherapy
  • At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis (6 weeks for radiotherapy to other substantial amount of bone marrow)
  • Recovered from prior radiotherapy

Surgery:

  • Not specified

Other:

  • No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone, or chloroquine)
  • No concurrent enzyme-activating anticonvulsants
  • No concurrent proton pump inhibitors or H_2 blockers within 4 hours of gefitinib administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040781

  Hide Study Locations
Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 94304
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2916
United States, Georgia
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
United States, Indiana
Riley Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-2899
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9063
Texas Children's Cancer Center
Houston, Texas, United States, 77030-2399
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Najat C. Daw, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069406, COG-ADVL0016, NCI-03-C-0062
Study First Received: July 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00040781     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Gefitinib
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009