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

Completed · Phase 1

Conditions studied: Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal

In brief

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

Key facts

Study ID

NCT01671592

Run by

Pawel Kalinski

People needed

6

Starts

2013-01-01

Expected to finish

2014-04-01

Last updated by the study team

2017-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have adequate tumor tissue from surgery, performed as part of their conventional care.
• No chemotherapy, radiotherapy, major surgery, or biologic therapy for their malignancy in the 2 weeks prior to vaccine administration and they must have recovered from all side effects.
• An ECOG performance status of 0, 1, or 2.
• Age equal to 18 years or older.
• Blood tests:
• Platelet counts greater than 80,000 (platelet count, hematocrit, and WBC will be re-evaluated within 2 weeks prior to leukapheresis)
• Hematocrit > 27.0
• White blood count > 2000/µL
• Creatinine less than or equal to 2 X ULN
• Aware of the neoplastic nature of his/her illness, the experimental nature of the study intervention, alternative treatments, potential benefits and risks, and willing to sign a written informed consent document.

You may not qualify if…

• Subjects currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 2 weeks after removal from immunosuppressive treatment. Subjects on maintenance steroids because of adrenal insufficiency are eligible.
• Subjects with total bilirubin greater than 2 X ULN.
• Subjects with uncontrolled pain.
• Subjects with active autoimmune disease, positive serology for HIV, HBV, or HCV. (Hypothyroidism is allowed.)
• Subjects who are allergic to or develop an allergy to heparin.
• Subjects who are pregnant.
• Subjects who have sensitivity to drugs that provide local anesthesia.
• Subjects who have medical contraindications for MRI. Such contraindications include:
• Electrical implants such as cardiac pacemakers or perfusion pumps
• Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye or steel implants
• Ferromagnetic objects such as jewelry or metal clips in clothing
• Pre-existing medical conditions, including claustrophobic reactions, the likelihood of developing a seizure or any greater than normal potential for cardiac arrest

Where it is running

• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.