- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02142335
Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
A Phase II Trial of the Combination of Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
연구 개요
상세 설명
Rituxan and Abraxane are approved for the treatment of other cancers, but not for melanoma. Candidates for this study have melanoma that has spread to their lymph nodes or internal organs and that cannot be removed by a surgical procedure.
The safety of this combination of drugs will also be looked at throughout this study.
Rituxan will be administered IV at weeks 1 and 3 of each cycle. Abraxane will be administered IV weekly for 3 consecutive weeks. This is followed by 1 week of rest after which, the cycle is repeated. Following the second cycle, there will be a 4-week period of rest. Evaluation of response will occur on day 71 +/-3 days. If either disease stabilization or clear evidence of clinical response is observed two additional cycles of treatment will be administered. Lesions will be measured on the scan (CT or PET/CT), x-ray
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Edward F McClay, MD
- 전화번호: 760-452-3340
- 이메일: emcclay@pacificoncology.com
연구 연락처 백업
- 이름: Beth Kimball, OCN, RN
- 전화번호: 760-452-3909
- 이메일: bkmball@pacificoncology.com
연구 장소
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California
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Encinitas, California, 미국, 92024
- 모병
- California Cancer Associates For Research,cCARE
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연락하다:
- Edward F McClay, M.D.
- 전화번호: 760-452-3340
- 이메일: emcclay@pacificoncology.com
-
연락하다:
- Beth c Kimball, RN, OCN
- 전화번호: 760-452-3909
- 이메일: bkimball@pacificoncology.com
-
수석 연구원:
- Edward F. McClay, M.D.
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부수사관:
- Alberto Bessudo, M.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must have inoperable stage III and IV melanoma.
Patients will be included in the trial based on the following criteria:
Patients previously treated with no more than 1 non-abraxane containing chemotherapy regimen or patients with the B-Raf mutation, who have received vemurafenib or the combination of Dabrafinib and trametinib (or similar compound on clinical trial) and progressed, who have documented surgically inoperable stage III or IV metastatic melanoma on pathologic examination of tissue. Previous treatment with immunotherapy is allowed. Patients who have been treated with either immunotherapy or chemotherapy must have be either 4 weeks from their last treatment or have fully recovered from all previous treatment.
Measurable or evaluable non-CNS disease required as defined:
- Uni-dimensionally measurable lesion as determined by physical exam, X-ray, CT scan, MRI, or other radiographic procedure.
- Lesion that can be seen on a radiologic test but is not uni-dimensionally measurable
- Previously irradiated lesion allowed only with documentation of progression if no other metastatic site present.
No active brain metastases Patients with previously treated brain metastases that have responded to therapy will be allowed on study assuming there is measurable disease outside of the CNS. Active therapy for the CNS disease must be completed a minimum of 3 weeks for chemotherapy and 6 weeks for radiation therapy (prior to enrollment on this study).
Prior/ Concurrent therapy
Biologic therapy No concurrent biological therapy with the exception of growth factors for anemia, neutropenia or thrombocytopenia.
Chemotherapy No greater than 1 previous non-abraxane containing chemotherapy treatment allowed
Radiotherapy At least 6 weeks since completion of radiotherapy
Patient characteristics Age and ability to give informed consent Patients must be 18 years of age or older. Patients must have the ability to give informed consent.
Performance status ECOG 0-2 Life expectancy of at least 3 months
General Medical Concerns:
- Normal organ function, except if abnormal due to tumor involvement.
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.
- Subject has provided written informed consent.
Rituximab-Specific Concerns:
- ANC: > 1200/mm3
- Platelets: > 100,000/mm3
- Hemoglobin: > 9 gm/dL
- Adequate renal function as indicated by serum creatinine measurement < 1.5 x the upper limit of normal or GFR > 50 ml/min.
- Adequate liver function, as indicated by bilirubin < 3.0
- AST or ALT <2x Upper Limit of Normal unless related to primary disease.
- AST or ALT <5x Upper limit of Normal if evidence of liver metastasis.
Exclusion Criteria:
- Life expectancy less than 3 months
Untreated brain metastasis
Previous treatment with Abraxane containing regimen
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 |
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실험적: Rituxan/Abraxane
This is a single arm study.
All patients recieve treatment.
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The dose of Rituxan is 375 mg/m2¬ administered as an IV infusion during weeks 1 & 3 (days 1 & 15)Abraxane will be administered at a fixed dose of 100 mg/m2 as an IV infusion weekly for three weeks in a row followed by one week of rest
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall response as determined by a Percent change (%) in the sum of the diameters of target lesions.
기간: baseline-12 weeks
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Evaluation of response (Progression Free and overall survival will be determined by measuring and recording the largest diameter of a lesion. Add these values together and record the value as the sum of the largest diameters.The percent change will be obtained according to the following formula: Percent change = sum of the longest diameter at 12weeks X 100 Sum of the longest diameters pre treatment |
baseline-12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Response rate as Percent change in diameter (mm) of target lesions
기간: 2 years
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Overall response rate ( complete response + Partial response) will be determined by the disappearance of lesions or a reduction of target lesions in short axis to <10mm (CR) + at least a 30% decrease in the sum of the longest diameters of the target lesions (PR).
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Edward F. McClay, M.D., California Cancer Assocaties for Research & Excellence
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 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
- ML29065
- 20132169 (기타 식별자: WIRB)
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. .
Rituxan에 대한 임상 시험
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Institute of Hematology & Blood Diseases Hospital...Henan Cancer Hospital; The Second Affiliated Hospital of Kunming Medical University; Langfang...완전한
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University Hospital, Toulouse완전한한랭글로불린혈증 | 한랭응집소병 | 천포창 | 자가면역성 혈소판감소성 자반증 | 용혈성 자가면역성 빈혈프랑스
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National Institute of Allergy and Infectious Diseases...Rho Federal Systems Division, Inc.; Clinical Trials in Organ Transplantation in Children완전한
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SandozHexal AG완전한
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Mayo ClinicNational Cancer Institute (NCI)완전한
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National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN); Blood and Marrow Transplant...모병재발성 다발성 경화증 | 재발 완화 다발성 경화증 | 속발성 진행성 다발성 경화증미국
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Johns Hopkins UniversityPatient-Centered Outcomes Research Institute; National Multiple Sclerosis Society모병