Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer

Trial Information

Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer

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.