- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00006009
Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma
A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma.
연구 개요
상세 설명
OBJECTIVES:
- Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas.
- Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population.
- Determine the response in these patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed weekly for 1 month and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.
연구 유형
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Stanford, California, 미국, 94305-5408
- Stanford University Medical Center
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참여기준
자격 기준
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건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed CD3+ T-cell lymphoma for which no standard curative therapy exists
Peripheral T-cell lymphoma
- Recurrent and/or progressive disease after at least 1 prior therapy
Mycosis fungoides
Stage IB/IIA
- Recurrent and/or progressive disease after at least 2 prior therapies
Stage IIB-IVB
- Recurrent and/or progressive disease after at least 1 prior therapy
All other T-cell lymphomas
- Recurrent and/or progressive disease after at least 1 prior therapy
Evaluable disease
- Any nodal site or mass lesion at least 1.5 cm in longest axis on physical exam or CT scan
- Skin lesions at least 1 cm in longest axis for cutaneous lymphoma
- High numbers of circulating T-cells allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
- Karnofsky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 2,000/mm^3*
- Absolute neutrophil count at least 1,000/mm^3*
- Platelet count at least 75,000/mm^3* NOTE: * Unless due to lymphoma
Hepatic:
- Bilirubin no greater than 2.0 times normal*
- AST/ALT no greater than 2.5 times upper limit of normal*
- Hepatitis B and C negative NOTE: * Unless due to lymphoma
Renal:
- Not specified
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other:
- No other uncontrolled illness
- No ongoing or active infection
- No other active malignancies except basal cell skin cancer or carcinoma in situ of the cervix
- HIV-1 negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Biologic therapy:
- At least 60 days since prior humanized or chimeric antibody therapy
Chemotherapy:
- At least 3 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 30 days since prior investigational drugs or therapies
공부 계획
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디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Youn H. Kim, MD, Stanford University
연구 기록 날짜
연구 주요 날짜
연구 시작
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- SUMC-NCI-102
- CDR0000068017 (레지스트리 식별자: PDQ (Physician Data Query))
- NCI-102
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