- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00992745
A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer
연구 개요
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Laguna Niguel, California, 미국, 92677
- West Coast Radiology Centers
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Newport Beach, California, 미국, 92663
- Pacific Coast Imaging
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San Francisco, California, 미국, 94143
- University of California - San Francisco
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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland
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New York
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New York, New York, 미국, 10065
- New York Presbyterian Hospital - Weill Cornell Medical College
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Texas
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Houston, Texas, 미국, 77030
- Vanguard Urologic Research Foundation
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Subjects must meet all of the following criteria to be enrolled in this study.
- Male aged 18 years or older
- Signed written informed consent and willingness to comply with protocol requirements
- Histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a metastatic lesion.
Evidence of metastatic disease as documented by an abnormal bone scan and CT scan or MRI plus:
Castration/anti androgen therapy naïve/sensitive:
- Gleason Score ≥ 7 and PSA ≥ 2.0 ng/mL with history of prostatectomy or primary radiation therapy of the prostate gland and prior undetectable PSA or; PSA > 10.0 ng/mL if intact prostate, or
- Gleason score ≤ 6 and PSA is ≥ 20 ng/mL, or
- Gleason Score ≥ 8 and any doubling of PSA, or PSA > 0.5 ng/mL, or
- Clinical Stage 3 and Gleason Score ≥ 8
If on anti androgen therapy, must have initiated therapy at least 4 weeks prior to treatment.
Castration/anti androgen therapy resistant:
- Patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (LHRH analogue); anti androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on anti androgens who have demonstrated a > 3 month duration of beneficial response to anti androgens; progression is demonstrated by any of the following:
I. PSA progression: 2 serial rising PSA determinations at least 14 days apart over the PSA nadir, with the last measurement ≥ 2 ng/mL
II. Progression of measurable disease, or progression of non measurable disease as defined by:
i. Soft tissue disease: The appearance of one or more new lesions, and/or unequivocal worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response, or ii. Bone disease: Appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre castration studies if there was no response.
III. Increased uptake of pre existing lesions on bone scan does not constitute progression.
IV. Testosterone ≤ 50 ng/dL achieved via medical or surgical castration.
- Male subjects who are fertile agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method throughout the study period. A second form of barrier birth control must be utilized if a subject's partner is using oral contraception until at least seven days after the last injection.
- Karnofsky performance is ≥ 50
Adequate hematologic, renal and liver function:
- WBC ≥ 2.0×103/mm3 (ANC > 1.0 x 103 mm3)
- Platelet count ≥ 75×103/mm3
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 2.5 mg/dL
- Total bilirubin ≤ 2x ULN
- AST, ALT ≤ 5x ULN
Exclusion Criteria:
- Karnofsky performance status of < 50
- Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants or 12 months for 125I implants
- Subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
- Subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study
- Any treatment with radiopharmaceuticals, e.g. Strontium 89 and Samarium 153 within 6 months prior to enrollment
- Ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. Patients who demonstrate an antiandrogen withdrawal response, defined as a > 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non steroidal anti androgen, are not eligible until the PSA rises above the nadir observed after anti androgen withdrawal
- Initiation of bisphosphonate therapy within 28 days prior to enrollment. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study
- Subject has any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow up examinations
- Subject is determined by the Investigator to be clinically unsuitable for the study
- If the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Previous ProstaScint®
Subjects with a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 alone.
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Single 10 mCi intravenous injection
다른 이름들:
Single 5 mCi intravenous injection
다른 이름들:
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실험적: No Previous ProstaScint®
Subjects without a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 and 111-In capromab pendetide imaging.
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Single 10 mCi intravenous injection
다른 이름들:
Single 5 mCi intravenous injection
다른 이름들:
Single 5 mCi intravenous injection
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Estimate the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide in subjects with metastatic prostate cancer by determining the presence and extent of the disease.
기간: 24 hours post-injection
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24 hours post-injection
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2차 결과 측정
결과 측정 |
기간 |
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Examine the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide on a per lesion basis in subjects with metastatic prostate cancer
기간: Through 2 weeks post-injection
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Through 2 weeks post-injection
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To describe the safety of administering 10.0 mCi and 5.0 mCi of 123I MIP 1072 for the detection of metastatic prostate cancer
기간: Through 2 weeks post-injection
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Through 2 weeks post-injection
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mack Roach, MD, University of California, San Francisco
- 수석 연구원: Jeffrey Dobkin, MD, Pacific Coast Imaging
- 수석 연구원: Stanley Goldsmith, MD, NY Presbyterian Hospital - Weill Cornell Medical Center
- 수석 연구원: Edward Coleman, MD, Duke University
- 수석 연구원: Arif Hussain, MD, University of Maryland
- 수석 연구원: Kevin Slawin, MD, Vanguard Urologic Research Foundation
- 수석 연구원: Samuel L Kipper, MD, West Coast Radiology Centerse
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 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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123-I-MIP-1072에 대한 임상 시험
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Alseres Pharmaceuticals, Inc알려지지 않은
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