- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00667017
RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells.
PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the response rate of patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma (CTCL) following treatment with RFT5-dgA immunotoxin (anti-CD25 immunotoxin IMTOX25) .
Secondary
- Determine whether responses correlate with the level of CD25+ expression on the CTCL tumor cells.
- Determine whether changes in the pre-treatment and the post-treatment levels of CD4+CD25+ Treg cells correlate with responses.
OUTLINE: Patients receive anti-CD25 immunotoxin IMTOX25 IV over 4 hours on days 1, 3, and 5. Treatment repeats every 6 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Tissue and blood samples are collected at baseline, and during study for CD25+ expression by fluorescent-activated cell sorter analysis, immunohistochemistry.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Texas
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Dallas, Texas, 미국, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed cutaneous T-cell non-Hodgkin lymphoma (CTCL)
Relapsed or refractory disease, meeting 1 of the following criteria:
- Progression of disease following 2 prior chemotherapies
- Failure to respond to the second prior chemotherapy
- Measurable disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Serum creatinine < 1.5 times upper limit of normal (ULN)
- Serum AST/ALT < 2.5 times ULN
- Total bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL in patients with Gilbert syndrome)
- WBC count ≥ 3,000/mm³
- Platelet count ≥ 100,000/mm³
- Serum albumin > 2.5 g/dL
- LVEF ≥ 45% by 2-D ECHO or MUGA scan
- Human antimurine antibody < 1 μg/mL
- Patients with a history of electrocardiogram abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test (i.e., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test)
- Must be willing to undergo venipuncture and central line placement
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HBV surface antigen, HCV, or HIV antibody positivity
- No autoimmune disease or immunodeficiency (i.e., HIV)
No history of uncontrolled concurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Ongoing or active cardiac disease (i.e., congestive heart failure, unstable angina pectoris, or cardiac arrhythmia)
- Psychiatric illness and/or social situation that would preclude study compliance
- No other malignancies except treated basal cell or squamous cell carcinoma of the skin, or treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 weeks since prior systemic therapy for CTCL
- More than 6 months since prior chronic steroid therapy or chronic anti-coagulation therapy
- No prior therapy with anti-CD25 immunotoxin IMTOX25 and/or Ontak
- No other concurrent cancer chemotherapy, experimental therapy, investigational agent, or immunomodulating agent (including steroids)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: IMTOX25 at 2mg/m²/dose
Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses.
A total of 6 cycles of treatment will be allowed.
A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response Rate - Cutaneous T Cell Lymphoma (CTCL)
기간: Once a week for seven weeks
|
Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
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Once a week for seven weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Simrit Parmar, MD, Simmons Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- SCCC-02407
- CDR0000594170 (레지스트리 식별자: PDQ (Physician Data Query))
- SCCC-122007-014
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