- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00602199
ABT-510 in Treating Patients With Metastatic Melanoma
A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510
RATIONALE: ABT-510 may stop the growth of melanoma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well giving ABT-510 works in treating patients with metastatic melanoma.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- Examine the safety profile of ABT-510 in patients with metastatic malignant melanoma.
- Examine the antitumor activity (i.e., time to progression and response rates) in patients treated with ABT-510.
- Determine the pharmacodynamic effects of ABT-510 and its potential impact on immune cell function in these patients.
OUTLINE: Patients receive ABT-510 subcutaneously twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are obtained at baseline, before treatment on day 1 of cycles 2 and 3, and then every other course thereafter for pharmacological and ancillary studies. Samples are evaluated for EC enumeration, expression profiling, circulating tumor cell quantification, analysis of T-cell functions (i.e., immunophenotyping for NK-, T- and B-cell phenotypes as well as ELISPOT analysis against common environmental pathogens and T cell spectratyping), and angiogenesis bioassays. Patients also undergo ultrasound-guided core tumor biopsies for histological analysis of microvascular density (CD38 and von Willebrand Factor immunohistochemistry) at baseline and before treatment on day 1 of courses 3 and 5.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
연구 유형
등록 (예상)
단계
- 2 단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
- Stage IV disease
- No known potentially curative standard therapy that exists or is proven capable of extending life expectancy
- Measurable disease
No history of or current CNS metastases
- MRI of the brain to confirm absence of CNS metastases within the past 28 days is required
- No known, presently active carcinomatous meningitis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 6 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Creatinine ≤ 2.5 times ULN
- Hemoglobin ≥ 9.0 g/dL
- Prothrombin time normal
- Willing to return to Mayo Clinic Rochester, Jacksonville or Scottsdale for follow-up
- Must be able to self-administer or has a caregiver who can reliably administer subcutaneous injections
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled or current infection
- No New York Heart Association class III-IV heart disease
- No recent history of (i.e., ≤ 12 weeks from study day 1) or current cancer-related bleeding event (e.g., hemoptysis)
- No recent history of (within the past 4 weeks) or current noncancer-related clinically significant bleeding event
- No uncontrolled hypertension
- No history of stroke or other CNS bleeding events (e.g., aneurysms)
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin C or nitrosoureas)
- At least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or surgery
- No concurrent anticoagulation therapy or antiplatelet therapy
- No other concurrent antineoplastic agents (e.g., cytotoxic chemotherapy, immunotherapy, radiotherapy, or investigational therapy) except local radiotherapy for supportive reasons involving a small radiation field
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
---|
18-week progression-free survival rate
|
2차 결과 측정
결과 측정 |
---|
전체 생존 시간
|
Objective response rate as defined by RECIST criteria
|
Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment
|
공동 작업자 및 조사자
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000582475
- P30CA015083 (미국 NIH 보조금/계약)
- MC0375 (기타 식별자: Mayo Clinic Cancer Center)
- 1439-04 (기타 식별자: Mayo Clinic IRB)
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. .
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