safety of labeled dendritic cell (dc) vaccines and feasibility of tracking by magnetic resonance imaging (mri)

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

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

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.

Eligibility criteria:
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

Keywords: cancer colorectal tumor neoplasms carcinoma vaccine