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| 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: | Primary Purpose: 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 |
| Study Start Date: | June 2002 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 6 months since prior allogeneic stem cell transplantation (SCT)
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 23 Study Locations| Study Chair: | Najat C. Daw, MD | St. Jude Children's Research Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00040781 History of Changes |
| Obsolete Identifiers: | NCT00050739 |
| Other Study ID Numbers: | CDR0000069406, COG-ADVL0016, NCI-03-C-0062 |
| Study First Received: | July 8, 2002 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
unspecified childhood solid tumor, protocol specific |
|
Neoplasms Gefitinib Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |