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

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT01671592
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: Phase 1
• Start date: January 2013
• Completion date: April 2014