- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00616005
Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide
Phase II Treatment of Adults With Primary Malignant Glioma With Irinotecan Plus Temozolomide
Objective:
To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide
연구 개요
상세 설명
Objectives of study are to determine activity of combo of Irinotecan + Temozolomide & to further characterize any toxicity associated w combo of Irinotecan + Temozolomide. Temozolomide administered orally at 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temozolomide administered on day 1 of treatment cycle & every 24hrs thereafter for 5 days w treatment cycles repeated every 6wks. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. At end of 3rd cycle/if cycles are stopped early for toxicity or progression, subject will undergo radiation therapy. CPT-11 administered intravenously in fasting state over 90min. CPT-11 will begin 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11 administered on days 1, 8, 22, & 29 of 6wk treatment cycle. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. Dose of CPT-11 will be based on whether pt is receiving CYP3A4-inducing antiepileptic drugs due to increased drug clearance produced by these agents. For pts receiving EIAEDs including phenytoin, fosphenytoin, oxcarbazepine, phenobarbital/ primidone, CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of125 mg/m2 administered.
Subjects have newly diagnosed histologically proven supratentorial glioblastoma multiforme. Toxicities associated w CPT-11 are anemia, decreased blood counts, diarrhea, constipation, nausea, vomiting, tiredness, fever, mouth sores, dehydration, rash, itching, changes in skin color, swelling, numbness, tingling, dizziness, confusion, low blood pressure, sweating, hot flashes, hair loss, inflammation of liver, flu-like symptoms, decreased urine output, shortness of breath,& pneumonia. Low white blood cell & platelet counts may be associated w risk of infection/bleeding, respectively. Irinotecan has also caused birth defects in animals. Most frequent toxicities in earlier studies have been low white blood cells & diarrhea, & death has been seen from these & other side effects. Temozolomide has been well tolerated by both adults & children w most common toxicity being mild myelosuppression. Other, less likely, potential toxicities include nausea & vomiting, constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy, hepatotoxicity, anorexia, fatigue & hyperglycemia. Hypersensitivity reactions have not yet been noted w Temozolomide. As in case w many anti-cancer drugs, Temozolomide may be carcinogenic.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
North Carolina
-
Durham, North Carolina, 미국, 27710
- Duke University Health System
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Pts have histologically proven supratentorial GBM
- Pts have newly diagnosed disease
- There must be measurable disease on contrast-enhanced magnetic resonance imaging performed <14 days before drug administration. Those who underwent resection must have MRI <72 hrs/ >14 days after surgery
- Prior Surgical Resection/Biopsy: Although surgical resection is not required, pts must be treated <42 days of surgery or biopsy
- Age >18 yrs
- Karnofsky Performance Status >70 percent
- Serum creatinine < 1.5 x ULN
- Absolute neutrophil count >1500 cells/microliter; platelet count >100,000 cells/microliter
- Serum SGOT & total bilirubin <2.5 x ULN
- Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
- Pts must agree to practice effective birth control measures while on study & for 2 months after completing therapy
Exclusion Criteria:
- Pregnant/breast feeding women / women/men w reproductive potential not practicing adequate contraception. This therapy may be associated w potential toxicity to fetus/child that exceeds minimum risks necessary to meet health needs of mother
- Active infection requiring intravenous antibiotics
- Known diagnosis of HIV infection
- Pts w history of another primary malignancy that currently requires active intervention
- Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition
- Pts who underwent surgical resection for GBM <2 weeks of start of treatment
- Pts who have received prior chemo, biologic therapy, XRT, interstitial brachytherapy/radiosurgery to brain
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: 1
Pts taking EIAEDs
|
Temozolomide-orally 200mg/m2 in fasting state 1hr prior to CPT-11 infusion.
Temozolomide-day 1 of treatment cycle & every 24hrs thereafter for 5days w treatment cycles repeated every 6wks.
Treatment cycles repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression.
CPT-11-intravenously in fasting state over 90min.
CPT-11 1hr after Temozolomide administration on day 1 of treatment cycle.
CPT-11-days 1, 8, 22, & 29 of 6wk treatment cycle.
Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression.
Dose of CPT-11 will be based on whether pt is receiving EIAEDs due to increased drug clearance produced by agents.
For pts receiving EIAEDs, CPT-11 dose of 325mg/m2 administered.
For pts not receiving EIAEDs, CPT-11 dose of 125mg/m2 administered.
다른 이름들:
|
다른: 2
Pts not taking EIAEDs
|
Temozolomide-orally 200mg/m2 in fasting state 1hr prior to CPT-11 infusion.
Temozolomide-day 1 of treatment cycle & every 24hrs thereafter for 5days w treatment cycles repeated every 6wks.
Treatment cycles repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression.
CPT-11-intravenously in fasting state over 90min.
CPT-11 1hr after Temozolomide administration on day 1 of treatment cycle.
CPT-11-days 1, 8, 22, & 29 of 6wk treatment cycle.
Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression.
Dose of CPT-11 will be based on whether pt is receiving EIAEDs due to increased drug clearance produced by agents.
For pts receiving EIAEDs, CPT-11 dose of 325mg/m2 administered.
For pts not receiving EIAEDs, CPT-11 dose of 125mg/m2 administered.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
무진행 생존
기간: 6 개월
|
6 개월
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Toxicity assessment
기간: 6 months
|
6 months
|
공동 작업자 및 조사자
스폰서
협력자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 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
- Pro00012939
- 8044 (기타 식별자: DUMC)
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. .
교모세포종에 대한 임상 시험
-
Celldex Therapeutics완전한교모세포종 | 교육종 | 소세포 교모세포종 | 거대 세포 교모세포종 | Oligodendroglial 성분을 가진 Glioblastoma미국, 캐나다, 호주, 이스라엘, 대만, 영국, 벨기에, 프랑스, 스페인, 독일, 오스트리아, 브라질, 콜롬비아, 체코, 그리스, 헝가리, 인도, 이탈리아, 멕시코, 네덜란드, 뉴질랜드, 페루, 스위스, 태국
-
Celldex Therapeutics완전한교모세포종 | 교육종 | 재발성 교모세포종 | 소세포 교모세포종 | 거대 세포 교모세포종 | Oligodendroglial 성분을 가진 Glioblastoma | 재발된 교모세포종미국
Temodar and Irinotecan에 대한 임상 시험
-
Tactical Therapeutics, Inc.모집하지 않고 적극적으로
-
University of OregonSpecial X Inc.모병부모-자녀 관계 | 육아 | 아동 행동 | 발달 장애 | 개발 지연 | 발달 장애, 아동미국
-
University Hospitals Cleveland Medical Center알려지지 않은
-
San Diego State UniversityRady Children's Hospital, San Diego알려지지 않은
-
Istituto per la Ricerca e l'Innovazione BiomedicaFondazione di Comunità di Messina onlus모병
-
GenSight Biologics모병
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Splendor-NC모병비만 | 초과 중량 | 체중 | 체중 감량 | 체중 변화 | 만성 질환 | 과체중 및 비만 | 신체 활동 부족 | 행동, 식사 | 중량 감소미국
-
Dalarna UniversityUppsala University; The Swedish Research Council모병백치 | 가벼운 인지 장애 | 치매, 혼합 | 알츠하이머형 치매 | 주관적 인지 장애 | 치매 노인성스웨덴
-
Children's National Research InstituteAppleTree Institute; The Maddux School초대로 등록
-
Northwestern UniversityUniversity of Michigan; The University of Texas Health Science Center at San Antonio; University... 그리고 다른 협력자들완전한