Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)
Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
2 other identifiers
interventional
6
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2012
CompletedFirst Posted
Study publicly available on registry
August 23, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedSeptember 26, 2017
September 1, 2017
1.2 years
August 20, 2012
September 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse events from the labeled DC vaccine
1 year
Ability to track the labeled DC vaccine by MRI
1 year
Secondary Outcomes (2)
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.
1 year
May assess the disease-free survival and overall survival
5 years
Study Arms (4)
Day 1 MRI with low dose vaccine
EXPERIMENTALDC 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.
Day 3 MRI with low dose vaccine
EXPERIMENTALDC 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.
Day 1 MRI with high dose vaccine
EXPERIMENTALDC 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.
Day 3 MRI with high dose vaccine
EXPERIMENTALDC 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.
Interventions
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pawel Kalinskilead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David L. Bartlett, MD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
August 20, 2012
First Posted
August 23, 2012
Study Start
January 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
September 26, 2017
Record last verified: 2017-09