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Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01671592
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pawel Kalinski, University of Pittsburgh

Study Description
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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

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Colorectal Cancer Colorectal Carcinoma Colorectal Tumors Neoplasms, Colorectal Biological: DC Vaccine Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
Study Start Date : January 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: DC Vaccine
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
Experimental: 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.
 Biological: DC Vaccine
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
Experimental: 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.
 Biological: DC Vaccine
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
Experimental: 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.
 Biological: DC Vaccine
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events from the labeled DC vaccine [ Time Frame: 1 year ]
  2. Ability to track the labeled DC vaccine by MRI [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]

    Effectiveness of DC accumulation may be correlated with their effectiveness in inducing immune responses as measured by:

    • Increase in the magnitude in the DTH response to: A) autologous tumor lysates (primary endpoint of efficacy); B) KLH; and c) saline (control); all injected intradermally.
    • Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, using IFNγ-ELISPOT readout.
    • In any HLA-A2+ subjects on the protocol, we may evaluate peripheral blood CD8+ T cell responses against CRC-related peptide epitopes present, using IFN ELISPOT as readout.

  2. May assess the disease-free survival and overall survival [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671592


Locations
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United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Pawel Kalinski
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David L. Bartlett, MD University of Pittsburgh
More Information
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Responsible Party: Pawel Kalinski, Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01671592    
Other Study ID Numbers: 10-052
R01CA134633 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Keywords provided by Pawel Kalinski, University of Pittsburgh:
Cancer
colorectal
tumor
 neoplasms
carcinoma
vaccine
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases