- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01671592
Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)
Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15232
- UPMC Hillman Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Day 1 MRI with low dose vaccine
DC vaccine at 3 x 10e6 per course which consists of 3 daily intradermal doses per course with the MRI on day 1 of the course.
|
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
|
Experimentell: Day 3 MRI with low dose vaccine
DC vaccine at 3 x 10e6 per course which consists of 3 daily intradermal doses per course with the MRI on day 3 of the course.
|
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
|
Experimentell: Day 1 MRI with high dose vaccine
DC vaccine at 3 x 10e7 per course which consists of 3 daily intradermal doses per course with the MRI on day 1 of the course.
|
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
|
Experimentell: Day 3 MRI with high dose vaccine
DC vaccine at 3 x 10e7 per course which consists of 3 daily intradermal doses per course with the MRI on day 3 of the course.
|
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Adverse events from the labeled DC vaccine
Tidsram: 1 year
|
1 year
|
Ability to track the labeled DC vaccine by MRI
Tidsram: 1 year
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Comparative analysis of the effectiveness of lymph node accumulation of DC vaccines injected to resting versus pre-activated nodes (DCs injected on day 1 versus day 3 of the three day-long vaccination cycle.
Tidsram: 1 year
|
Effectiveness of DC accumulation may be correlated with their effectiveness in inducing immune responses as measured by:
|
1 year
|
May assess the disease-free survival and overall survival
Tidsram: 5 years
|
5 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: David L. Bartlett, MD, University of Pittsburgh
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-052
- R01CA134633 (U.S.S. NIH-anslag/kontrakt)
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