Colorectal Cancer Clinical Trial
Official title:
Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
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
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.
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