Gefitinib in Treating Children With Refractory Solid Tumors
A Phase I Study Of ZD1839 (Iressa TM), An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, In Children With Refractory Solid Tumors
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of gefitinib in children with refractory solid tumors.
II. Determine the dose-limiting toxicity of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine, preliminarily, the antitumor activity of this drug in these patients.
V. 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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Arcadia, California, 미국, 91006-3776
- Children's Oncology Group
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
- Performance status - Karnofsky 50-100% (over 10 years of age)
- Performance status - Lansky 50-100% (10 years of age and under)
- At least 8 weeks
- 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)
- 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
- Creatinine normal for age
- Glomerular filtration rate at least 70 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
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
- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No concurrent tamoxifen
- 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
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treatment (gefitinib)
Patients receive oral gefitinib once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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상관 연구
구두로 주어진
다른 이름들:
상관 연구
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by the Common Terminology Criteria (CTC) version 2.0
기간: 28 days
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28 days
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DLT defined as hematologic and non-hematologic toxicities toxicities attributable to drug administration occurring during or immediately subsequent to the first course as assessed by CTC version 2.0
기간: 28 days
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28 days
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Pharmacokinetics of gefitinib
기간: At baseline, at 1, 2, 4, 6, 8, 12, and 24 hours after administration, at days 21 and 28, and at day 28 of subsequent courses
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At baseline, at 1, 2, 4, 6, 8, 12, and 24 hours after administration, at days 21 and 28, and at day 28 of subsequent courses
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Antitumor activity of gefitinib according to Response Evaluation Criteria in Solid Tumor (RECIST)
기간: Up to 2 years
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Up to 2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Najat Daw, Children's Oncology Group
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCI-2012-01874
- U01CA097452 (미국 NIH 보조금/계약)
- ADVL0016
- CDR0000069406 (레지스트리 식별자: PDQ (Physician Data Query))
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