- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00004063
Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer
A Phase I-II Clinical Trial of Cisplatin (Platinol) Followed by Gemcitabine HCl (Gemzar) in Combination With Mild, Fever-Range Whole Body Hyperthermia (LL-WBH) at 40C in Patients With Advanced Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy and interferon alfa may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of cisplatin, gemcitabine, interferon alfa, and whole-body hyperthermia and how well they work in treating patients with metastatic, recurrent, or refractory cancer.
연구 개요
상세 설명
OBJECTIVES:
- Determine the toxicity and tumor response in patients with metastatic, recurrent, or refractory malignancies treated with cisplatin, gemcitabine, interferon alfa, and long-duration, low temperature whole body hyperthermia (LL-WBH).
OUTLINE: This is a dose escalation study of cisplatin.
- Phase I and II: Patients receive gemcitabine IV over 30 minutes on day 1 and 8. Patients receive cisplatin IV over 6 hours on day 15, followed by subcutaneous interferon alfa on days 16 and 17. Patients undergo long-duration, low temperature whole body hyperthermia over 6 hours plus gemcitabine over 30 minutes on day 17. Courses repeat every 5 weeks in the absence of disease progression or unacceptable toxicity.
- Phase I: Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity. The MTD of cisplatin is used for phase II study.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
-
-
Texas
-
Houston, Texas, 미국, 77225
- 모병
- University of Texas Health Science Center at Houston
-
연락하다:
- Joan M.C. Bull, MD
- 전화번호: 713-500-6820
- 이메일: joan.m.bull@uth.tmc.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic, recurrent, or refractory carcinoma
- Measurable disease by CT, MRI, or physical examination
- No brain metastases or other CNS disorders
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 90,000/mm^3
- Bone marrow cellularity normal on bone marrow biopsy
- No coagulopathy disorder
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT no greater than 2 times upper limit of normal
- PT less than 14 seconds
- PTT less than 35 seconds
- No inadequate liver function (no greater than 20% involvement)
Renal:
- Creatinine no greater than 1.8 mg/dL
- Creatinine clearance at least 45 mL/min
- BUN no greater than 25 mg/dL
Cardiovascular:
- Adequate cardiac function documented by history, physical exam, or stress exercise test (MUGA or ECHO) with resting blood pressure and heart rate increasing appropriately with exercise
- LVEF at least 45%
- No prior myocardial infarction
- No symptomatic coronary artery disease
- No angina
- No significant arrhythmia
- No uncontrolled hypertension
- No thromboembolic disease
Pulmonary:
- FEV_1 at least 70% of predicted
- Arterial PO_2 at least 60 mmHg on room air
- No massive (greater than 30% involvement) lung disease
- DLCO greater than 50% of predicted
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No seizure disorders
- No significant emotional instability
- No history of malignant hyperthermia following general anesthesia
- No other concurrent medical illness that would prevent compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- At least 6 days since major thoracic or abdominal surgery
Other:
- No concurrent cardiac glycosides, antiangina drugs, arrhythmia drugs, anticoagulants, thrombolytic agents, adrenal corticosteroids, or aspirin
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
|---|
|
무진행 생존
|
|
전반적인 생존
|
|
응답 시간
|
|
응답 시간
|
|
안정적인 질병의 기간
|
공동 작업자 및 조사자
수사관
- 연구 의자: Joan M.C. Bull, MD, The University of Texas Health Science Center, Houston
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
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
- CDR0000067264
- UTHSC-MS-99116
- NCI-V99-1561
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. .