Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/28/2017 |
| Start Date: | January 2013 |
| End Date: | April 2014 |
Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
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
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.
- 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
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