- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00002746
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients with myelodysplastic syndrome.
연구 개요
상세 설명
OBJECTIVES:
- Determine the safety, tolerance, and maximum tolerated dose of subcutaneous interleukin-2 (aldesleukin; IL-2) in patients with myelodysplastic syndrome (MDS).
- Evaluate the hematologic effects of subcutaneous IL-2 in MDS.
OUTLINE: IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks. After each cycle the patient will be evaluated for response. The patient could continue IL-2 therapy for up to 12 cycles. There are 4 dose levels of IL-2. At each dose level 3 patients will be accrued sequentially.
Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs. After the patient returns to baseline pretherapy values or grade I toxicity, the subject will resume IL-2 at 50% of the initial dose. If the patient again goes into grade III toxicity or is in need of hospitalization, IL-2 will be discontinued.
PROJECTED ACCRUAL: Between 12-24 patients will be accrued.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98195-6043
- University of Washington Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed myelodysplastic syndrome: Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML)
- No patients with refractory anemia with excess blasts in transformation (RAEB-t)
PATIENT CHARACTERISTICS:
Age:
- 15 and over
Performance status:
- Karnofsky 70-100
Hematopoietic:
- Platelet count greater than 20,000
Hepatic:
- Bilirubin less than 1.6 mg/dL
- SGOT less than 150 U/L
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No symptoms of coronary artery disease, congestive heart failure, edema, clinically manifest hypotension, presence of cardiac arrhythmias on EKG, or severe hypertension
Pulmonary:
- No significant pleural effusion, dyspnea at rest or severe exertional dyspnea
Other:
- No patients with nephrotic syndrome
- No uncontrolled infections or active peptic ulcer disease
- No serious intercurrent medical illness
- Not pregnant or nursing
- Adequate contraception required of all patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunosuppressive therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- At least 2 weeks since corticosteroid therapy
- At least 4 weeks since other endocrine therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
수사관
- 연구 의자: John A. Thompson, MD, Seattle Cancer Care Alliance
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 10469 (DAIDS ES Registry Number)
- UW-26-245-B
- NCI-V96-0848
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