전립선암 환자의 177Lu 방사성표지 단클론항체 HuJ591(177Lu-J591) 및 케토코나졸
국소 치료 후 생화학적으로 재발된 고위험 거세 전립선암 환자에서 177Lu 방사성 표지 단일클론 항체 HuJ591(177Lu-J591) 및 케토코나졸의 무작위 2상 시험
The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.
연구 개요
상태
정황
상세 설명
This research is being done because the standard treatments for prostate cancer that has returned (PSA is elevated) after surgery and/or radiation and progressed on initial hormonal therapy are not curative. Existing treatments, such as the ketoconazole used as part of this study may decrease PSA temporarily, but unfortunately the cancer continues to grow. This experimental drug is designed to seek out all of the prostate cancer cells and to deliver a lethal dose of radiation to the areas of cancer, but not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive some radiation dose that is within the acceptable limits.
The experimental drug in this study includes an antibody (abbreviated: mAb) called "J591". It is a protein molecule which can bind to a specific site on a prostate cancer cell. A very energetic radioactive (an unstable atom) metal called 177Lutetium (abbreviated: 177Lu) is attached to the J591 antibody. The fully assembled drug is called "177Lu-J591". The study will assess the potential of the energy given off by the radioactive compound to kill cancer cell. This study may also involve the use of 111Indium (abbreviated 111In). This is also an energetic radioactive particle, but does not generally give off enough energy to kill cancer cells, but allows researchers to take pictures. This radioactive particle is also attached to the J591 antibody (called 111In-J591) and will serve as a placebo (treatment with no active medicine).
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90048
- Cedars Sinai
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Los Angeles, California, 미국, 90089
- USC/Norris Comprehensive cancer center
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20007
- Georgetown University Medical Center
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University Melvin and Bren Simon Cancer Center
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospitals and Clinics
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Kansas
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Westwood, Kansas, 미국, 66205
- The University of Kansas Cancer Center
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Nebraska
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Omaha, Nebraska, 미국, 68130
- XCancer Omaha
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New York
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New York, New York, 미국, 10021
- Weill Cornell Medical College
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15232
- UPMC Hillman Cancer Center
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Utah
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Salt Lake City, Utah, 미국, 84108
- University of Utah
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.
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Biochemical progression (rising PSA) after medical or surgical castration
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High risk of systemic progression defined as:
- Rising PSA as defined above and either:
- Absolute PSA > 20 ng/mL AND/OR
- PSA doubling time < 8 months
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No evidence of local recurrence or distant metastases
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Age >18 years.
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Serum testosterone < 50 ng/ml
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Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
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Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
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Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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Use of red blood cell or platelet transfusions within 4 weeks of treatment
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Use of hematopoietic growth factors within 4 weeks of treatment
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Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
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Prior radiation therapy encompassing >25% of skeleton (see Appendix C)
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Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)
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Platelet count <150,000/mm3 or known primary qualitative platelet disorder
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Absolute neutrophil count (ANC) <2,000/mm3
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Hematocrit <30 percent and Hemoglobin < 10 g/dL
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Abnormal coagulation profile (PT or INR, PTT > 1.3x ULN) unless on therapeutic anticoagulation - see concomitant meds section
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Serum creatinine >2.5 mg/dL
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AST (SGOT) >2x ULN
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Bilirubin (total) >1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
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Active serious infection
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Active angina pectoris or NY Heart Association Class III-IV
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ECOG Performance Status > 2
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Life expectancy <12 months
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History of deep vein thrombosis and/or pulmonary embolus within 1 month of study entry
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Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
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Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational therapy is not permitted during the treatment phase.
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Prior use of ketoconazole for the purposes of prostate cancer therapy for greater than 1 month
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Known history of HIV. The effects of J591 are unknown in this population. Furthermore, ketoconazole has many well-described drug-drug interactions which could affect antiviral therapy. If necessary, this population will be studied separately.
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Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse.
- Known history of known myelodysplastic syndrome
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Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment
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Finasteride (Propecia® or Proscar®) or dutasteride (Avodart®) within 4 weeks of enrollment
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Patients on corticosteroids prior to enrollment must have either discontinued and shown biochemical progression or have biochemical progression on a stable dose
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1. 177Lu-J591 + Ketoconazole
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone |
177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment
다른 이름들:
Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
다른 이름들:
Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
다른 이름들:
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위약 비교기: 2. 111In-J591 + Ketoconazole
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone |
Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
다른 이름들:
Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
다른 이름들:
111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration
기간: Baseline and 18 months after study drug administration
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Subjects will perform a CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan to determine the proportion of participants free of radiographically evident metastases from baseline to 18 months after study drug administration. |
Baseline and 18 months after study drug administration
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in PSA Response Rate
기간: Collected at screening, V2, V3, V5, V9 then every 4 weeks till PSA progression or end of study at approximately 100 months
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PSA response will be determined by comparing the PSA levels after therapy to the baseline and pre-treatment PSA via blood specimens |
Collected at screening, V2, V3, V5, V9 then every 4 weeks till PSA progression or end of study at approximately 100 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Scott T Tagawa, M.D., Weill Medical College of Cornell University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
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
- 0810010067
- J591+Ketoconazole (기타 식별자: Weill Cornell Medicine)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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