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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pawel Kalinski, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01671592
First received: August 20, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Colorectal Neoplasms
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
Biological: DC Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Adverse events from the labeled DC vaccine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Ability to track the labeled DC vaccine by MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.

  • May assess the disease-free survival and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671592

Locations
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Pawel Kalinski
Investigators
Principal Investigator: David L. Bartlett, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Pawel Kalinski, Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01671592     History of Changes
Other Study ID Numbers: 10-052, R01CA134633
Study First Received: August 20, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Cancer
colorectal
tumor
neoplasms
carcinoma
vaccine

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases

ClinicalTrials.gov processed this record on November 27, 2014