NCT01671592

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pawel Kalinski · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Tumors
• Neoplasms, Colorectal

Interventions

Type	Name	Description
BIOLOGICAL	DC Vaccine	Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-08-23
• Last updated: 2017-09-26

Locations

1 site across 1 country: United States