Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
A Phase I Study of Thrombopoietin (rhTPO) Plus G-CSF in Children Receiving Ifosfamide, Carboplatin, and Etoposide (I.C.E.) Chemotherapy for Recurrent or Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
OBJECTIVES:
- Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin in children with solid tumors receiving myelosuppressive chemotherapy with ifosfamide, carboplatin, and etoposide (ICE).
- Determine a safe dose of recombinant human thrombopoietin with filgrastim (G-CSF) in this patient population.
- Evaluate the time to platelet count recovery following chemotherapy in this patient population.
- Evaluate the depth and duration of neutropenia and thrombocytopenia and the number of platelet transfusion events in this patient population.
OUTLINE: This is a dose escalation study of recombinant human thrombopoietin.
All patients receive chemotherapy consisting of carboplatin IV over 60 minutes on days 0 and 1 and etoposide and ifosfamide IV over 60 minutes on days 0-4. Chemotherapy is continued in the absence of disease progression or unacceptable toxicity for a maximum of 6 courses every 21 days.
Cohorts of 3-6 patients each receive escalating doses of recombinant human thrombopoietin IV on days 4, 6, 8, 10, and 12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 2 patients experience dose limiting toxicity. After the MTD is determined an additional cohort of patients are treated at this dose level every other day on days 4-20. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until absolute neutrophil count is greater than 1000/mm3 for 2 consecutive days or day 33.
PROJECTED ACCRUAL: A total of 24 evaluable patients will be accrued for this study.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
-
-
California
-
Long Beach, California, 미국, 90806
- Long Beach Memorial Medical Center
-
Los Angeles, California, 미국, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, 미국, 91010
- Beckman Research Institute, City of Hope
-
Los Angeles, California, 미국, 90027-0700
- Children's Hospital Los Angeles
-
Orange, California, 미국, 92668
- Children's Hospital of Orange County
-
San Francisco, California, 미국, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
-
-
District of Columbia
-
Washington, District of Columbia, 미국, 20010-2970
- Children's National Medical Center
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46202-5265
- Indiana University Cancer Center
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109-0752
- University Of Michigan Comprehensive Cancer Center
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55455
- University of Minnesota Cancer Center
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
-
-
Missouri
-
Kansas City, Missouri, 미국, 64108
- Children's Mercy Hospital - Kansas City
-
-
New York
-
New York, New York, 미국, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, 미국, 10016
- Kaplan Cancer Center
-
New York, New York, 미국, 10032
- Herbert Irving Comprehensive Cancer Center
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45229-3039
- Children's Hospital Medical Center - Cincinnati
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
-
Pittsburgh, Pennsylvania, 미국, 15213
- Children's Hospital of Pittsburgh
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37232-6838
- Vanderbilt Cancer Center
-
-
Texas
-
Houston, Texas, 미국, 77030
- University of Texas - MD Anderson Cancer Center
-
-
Utah
-
Salt Lake City, Utah, 미국, 84132
- Huntsman Cancer Institute
-
-
Washington
-
Seattle, Washington, 미국, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
-
Wisconsin
-
Madison, Wisconsin, 미국, 53792
- University of Wisconsin Comprehensive Cancer Center
-
-
-
-
Western Australia
-
Perth, Western Australia, 호주, 6001
- Princess Margaret Hospital for Children
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Histologically proven (except for brain stem tumors) malignancy that has
failed or relapsed after standard first-line antineoplastic therapy
- Sarcoma (soft tissue and bone)
- Kidney tumors
- Brain tumors
- Other solid tumors (gonadal and germ cell tumors, malignant melanoma,
- retinoblastoma, liver tumors, and miscellaneous tumors) Must have had recurrence within the past 4 weeks
No bone marrow involvement
No prior or concurrent myelogenous leukemia
PATIENT CHARACTERISTICS:
Age:
- 1 to 21
Performance status:
- Lansky or Karnofsky 60-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1000/mm3
- Platelet count greater than 100,000/mm3
- No grade III or IV thrombosis
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT less than 2.5 times ULN
Renal:
- Creatinine clearance or glomerular filtration rate at least 70 mL/min
Cardiovascular:
- Ejection fraction normal
- No evidence of arrhythmias requiring therapy
- Fractional shortening greater than 28%
Other:
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 10 days since prior colony-stimulating factor therapy and recovered
- At least 30 days since prior epoetin alfa
- No other concurrent cytokines, including epoetin alfa
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and
- recovered
- At least 3 months since therapy with etoposide, carboplatin, or ifosfamide
- that is identical to study treatment
Endocrine therapy:
- Not specified
Radiotherapy:
- Concurrent radiotherapy allowed after third course of therapy
- No prior cranial/spinal radiotherapy
- No prior radiotherapy to greater than 50% of bone marrow
Surgery:
- Concurrent surgery allowed after the second course of therapy
Other:
- No concurrent investigational agents
- No concurrent lithium, aspirin, coumadin, or heparin
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Cohort 1
Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5.
All patients receive recombinant human thrombopoietin (rhTPO).
rhTPO began on the last day of ICE (Ifosfamide, Carboplatin and Etoposide) chemotherapy (Day 4) and subsequent doses will be administered on Days 6, 8, 10 and 12 (5 doses total).
The initial dose of rhTPO was 1.2 μg/kg/dose and was subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated.
Therapy will continue for maximum six courses.
Pharmacokinetic data will be obtained (during course one only).
|
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
|
|
실험적: Cohort 2
Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5. All patients receive recombinant human thrombopoietin (rhTPO). The dose of rhTPO 1.2 μg/kg/dose and subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated. Patients assigned to Cohort II will receive pre-chemotherapy rhTPO at 3.6 μg/kg/dose on Days -5, -3, -1, and post-chemotherapy rhTPO on Days +4, +6, and +8 (6 doses total. Subsequent courses of chemotherapy will begin as soon as the ANC recovers to ≥ 1,000/μL and the platelet count to ≥ 100,000/μL between days 21 and 35. Therapy will continue for maximum six courses. Pharmacokinetic data will be obtained (during course one nly). For the second cohort, full data collection will occur for cycles one and two and limited data collection for cycles 3, 4, 5, and 6. |
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO)
기간: length of study
|
To determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO) in children receiving I.C.E.
myelosuppressive chemotherapy.
|
length of study
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluate the time for patients to demonstrate platelet recovery
기간: Length of study
|
To evaluate the time for patients to demonstrate platelet recovery following I.C.E.
chemotherapy with rhTPO + G-CSF.
|
Length of study
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 의자: Mitchell S. Cairo, MD, Herbert Irving Comprehensive Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
- 재발성 신세포암
- 상세불명 소아 고형 종양, 프로토콜 특이적
- 호중구 감소증
- 재발성 흑색종
- 재발성 안내 흑색종
- 혈소판 감소증
- 재발성 소아기 횡문근육종
- 재발성 신경모세포종
- 재발성 자궁 육종
- 재발 성 난소 생식 세포 종양
- 재발성 악성 고환 생식 세포 종양
- 재발성 유잉 육종/말초 원시 신경외배엽 종양
- 재발성 골육종
- 재발성 윌름스 종양 및 기타 소아 신장 종양
- 재발성 아동기 천막상원시신경외배엽종양
- 재발 성 소아 소뇌 성상 세포종
- 재발 성 소아 대뇌 성상 세포종
- 생식선외 생식 세포 종양
- 재발성 소아 간암
- 재발 성 소아 연조직 육종
- 재발성 소아기 뇌간 신경아교종
- 재발성 소아 수모세포종
- 소아기 중추 신경계 생식 세포 종양
- 소아 생식 세포 종양
- 재발성 망막모세포종
- 재발성 임신 융모성 종양
- 재발성 아동 시각 경로 신경아교종
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 09717
- CCG-09717
- CDR0000066668
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .