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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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