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

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:

MedlinePlus related topics: Cancer Colorectal Cancer MRI Scans

U.S. FDA Resources

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 ]

Estimated Enrollment:	12
Study Start Date:	January 2013
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 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.

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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 100,000 (platelet count, hematocrit, and WBC will be re-evaluated before leukapheresis, within 2 weeks)
- 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

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

Contacts

Contact: David L. Bartlett, MD	412-692-2852	bartlettdl@upmc.edu
Contact: Gail Tribble, RN, BSN, OCN	412-647-8205	tribbleg@upmc.edu

Locations

United States, Pennsylvania
UPMC Hillman Cancer Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

Pawel Kalinski

National Cancer Institute (NCI)

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:	January 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

Cancer
colorectal
tumor

neoplasms
carcinoma
vaccine

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013