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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms Colorectal Cancer Colorectal Carcinoma Colorectal Tumors Neoplasms, Colorectal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL