Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT01671592
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2012-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)
Sponsor:
Pawel Kalinski
Organization:
Study Overview
Official Title:
Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA134633 | NIH | None | https://reporter.nih.gov/quic… | View |