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Trial record 3 of 4 for:    klh | First posted from 07/01/2012 to 07/01/2013

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

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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

Tracking Information
First Submitted Date  ICMJE August 20, 2012
First Posted Date  ICMJE August 23, 2012
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
  • Adverse events from the labeled DC vaccine [ Time Frame: 1 year ]
  • Ability to track the labeled DC vaccine by MRI [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
  • 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.
  • May assess the disease-free survival and overall survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)
Official Title  ICMJE Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
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
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumors
  • Neoplasms, Colorectal
Intervention  ICMJE Biological: DC Vaccine
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: DC Vaccine
  • 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.
    Intervention: Biological: DC Vaccine
  • 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.
    Intervention: Biological: DC Vaccine
  • 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.
    Intervention: Biological: DC Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2014)
6
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2012)
12
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01671592
Other Study ID Numbers  ICMJE 10-052
R01CA134633 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pawel Kalinski, University of Pittsburgh
Study Sponsor  ICMJE Pawel Kalinski
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: David L. Bartlett, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP