Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)
2017년 9월 25일 업데이트: Pawel Kalinski
Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
This study will evaluate the safety and feasibility MRI tracking of a vaccine produced from a persons cancer cells injected intradermally once a day for 3 consecutive days.
One of the daily doses will contain a chemical that can be detected by an MRI.
That will be either the 1st or 3rd day of the 3 day course.
On that day MRI scans will be performed 6 and 24 hours after the injection on that day.
Patients may be able to receive booster doses every 1-2 months
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
STUDY EVALUATIONS
Pre-Vaccination
- Complete physical examination (with ECOG performance status (PS), medical history, weight, height, and BSA); the exact size and location of all tumor lesions will be noted in the flow sheet, documented in the text note, and by photographic and/or radiologic means
- CEA levels in the blood (as a tumor marker)
- Women of childbearing potential will have a serum beta-HCG pregnancy test
- Anti-HIV, HbsAg and Anti-HCV
- CBC, platelet, differential
- Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium, potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin
- PT/PTT testing
- Electrocardiogram (EKG), if indicated
- Radiologic imaging to evaluate the status of disease may be performed as a part of routine care.
- Leukapheresis
- Dendritic cell vaccine preparation
Procedures during priming vaccination (Days 1 to 3)
- Complete physical examination (with PS and weight)
- 19F/1H MRI scanning on day of vaccination, 6 hrs (±1 hour) and 24 hrs (±4 hour) post-injection.
- Blood for in vitro assays, before first i.d. administration on day 1 (baseline) and after the last i.d. administration on day 3
- DTH tests: administration on day 1 and readout on day 3
- Biopsy of the DTH site can be performed in any subject who consented to such biopsy, at the discretion of the investigator/sub-investigator (Day 3 only, based on readout)
Procedures on Day 15
- Complete physical examination (with ECOG PS and weight)
- CBC, platelet, differential
- Blood for in vitro assays
Procedures during booster courses (Days 36 to 38, 64 to 66, and 91 to 93)
- Complete physical examination (with PS and weight) on the 1st day of each 3 day course (Days 36, 64, and 91)
- CBC, platelet, differential on the 1st day of each 3 day course (Days 36, 64, and 91)
- Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium, potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin on the 1st day of each 3 day course (Days 36, 64, and 91)
- DTH tests: administration on 1st day and readout on 3rd day during 2nd and 3rd booster courses (Administration days 64 and 91, readout days 66 and 93)
- Biopsy of the DTH site can be performed in any subject who consented to such biopsy, at the discretion of the investigator/sub-investigator (3rd day of 3 day course, based on readout of DTH test)
- Blood for in vitro assays (1st and 3rd day of each 3 day course)
Procedures on Day 105
- Complete physical examination (with ECOG PS and weight)
- CEA levels in the blood (as a tumor marker)
- CBC, platelet, differential
- Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium, potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin
- Radiologic imaging to evaluate the status of disease may be performed as a part of routine care
- Photography
- Long term follow-up The subjects with lack of disease progression at 6 months after the last vaccination will be monitored for the disease free survival and overall survival. Subjects may be contacted every 3 months within the first three years after study intervention, every six months until year 5, and annually afterwards. In lieu of direct contact a medical record review may be performed to obtain the data for these time points for disease progression and/or survival.
연구 유형
연구 유형
중재적
등록 (실제)
등록
6
단계
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, 미국, 15232
- UPMC Hillman Cancer Center
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subjects must have adequate tumor tissue from surgery, performed as part of their conventional care.
- No chemotherapy, radiotherapy, major surgery, or biologic therapy for their malignancy in the 2 weeks prior to vaccine administration and they must have recovered from all side effects.
- An ECOG performance status of 0, 1, or 2.
- Age equal to 18 years or older.
Blood tests:
- Platelet counts greater than 80,000 (platelet count, hematocrit, and WBC will be re-evaluated within 2 weeks prior to leukapheresis)
- Hematocrit > 27.0
- White blood count > 2000/µL
- Creatinine less than or equal to 2 X ULN
- Aware of the neoplastic nature of his/her illness, the experimental nature of the study intervention, alternative treatments, potential benefits and risks, and willing to sign a written informed consent document.
Exclusion Criteria:
- Subjects currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 2 weeks after removal from immunosuppressive treatment. Subjects on maintenance steroids because of adrenal insufficiency are eligible.
- Subjects with total bilirubin greater than 2 X ULN.
- Subjects with uncontrolled pain.
- Subjects with active autoimmune disease, positive serology for HIV, HBV, or HCV. (Hypothyroidism is allowed.)
- Subjects who are allergic to or develop an allergy to heparin.
- Subjects who are pregnant.
- Subjects who have sensitivity to drugs that provide local anesthesia.
Subjects who have medical contraindications for MRI. Such contraindications include:
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye or steel implants
- Ferromagnetic objects such as jewelry or metal clips in clothing
- Pre-existing medical conditions, including claustrophobic reactions, the likelihood of developing a seizure or any greater than normal potential for cardiac arrest
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
4
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Day 1 MRI with low dose vaccine
DC vaccine at 3 x 10e6 per course which consists of 3 daily intradermal doses per course with the MRI on day 1 of the course.
|
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
|
|
실험적: Day 3 MRI with low dose vaccine
DC vaccine at 3 x 10e6 per course which consists of 3 daily intradermal doses per course with the MRI on day 3 of the course.
|
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
|
|
실험적: Day 1 MRI with high dose vaccine
DC vaccine at 3 x 10e7 per course which consists of 3 daily intradermal doses per course with the MRI on day 1 of the course.
|
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
|
|
실험적: Day 3 MRI with high dose vaccine
DC vaccine at 3 x 10e7 per course which consists of 3 daily intradermal doses per course with the MRI on day 3 of the course.
|
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Adverse events from the labeled DC vaccine
기간: 1 year
|
1 year
|
|
Ability to track the labeled DC vaccine by MRI
기간: 1 year
|
1 year
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Comparative analysis of the effectiveness of lymph node accumulation of DC vaccines injected to resting versus pre-activated nodes (DCs injected on day 1 versus day 3 of the three day-long vaccination cycle.
기간: 1 year
|
Effectiveness of DC accumulation may be correlated with their effectiveness in inducing immune responses as measured by:
|
1 year
|
|
May assess the disease-free survival and overall survival
기간: 5 years
|
5 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: David L. Bartlett, MD, University of Pittsburgh
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
연구 시작
2013년 1월 1일
기본 완료 (실제)
기본 완료
2014년 4월 1일
연구 완료 (실제)
연구 완료
2014년 4월 1일
연구 등록 날짜
최초 제출
최초 제출
2012년 8월 20일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2012년 8월 22일
처음 게시됨 (추정)
처음 게시됨
2012년 8월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2017년 9월 26일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2017년 9월 25일
마지막으로 확인됨
마지막으로 확인됨
2017년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 10-052
- R01CA134633 (미국 NIH 보조금/계약)
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. .