Colorectal NeoplasmsPhase 1NCT01671592
Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)
A Phase 1 study testing DC Vaccine in people with Colorectal Neoplasms and Colorectal Cancer, run by Pawel Kalinski at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma
- What is being tested?
- DC Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: 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
Read the detailed description
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.
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
- Being tested
- DC Vaccine
- Keywords
- Cancer, colorectal, tumor, neoplasms, carcinoma, vaccine
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC VaccineBiological
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
| Study group | Role | What they receive |
|---|---|---|
| Day 1 MRI with low dose vaccine | Experimental | 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. Receives: Biological: DC Vaccine |
| Day 3 MRI with low dose vaccine | Experimental | 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. Receives: Biological: DC Vaccine |
| Day 1 MRI with high dose vaccine | Experimental | 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. Receives: Biological: DC Vaccine |
| Day 3 MRI with high dose vaccine | Experimental | 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. Receives: Biological: DC Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events from the labeled DC vaccine
Measured: 1 year
Ability to track the labeled DC vaccine by MRI
Measured: 1 year
Secondary outcomes (2)
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.
Effectiveness of DC accumulation may be correlated with their effectiveness in inducing immune responses as measured by:
- Increase in the magnitude in the DTH response to: A) autologous tumor lysates (primary endpoint of efficacy); B) KLH; and c) saline (control); all injected intradermally.
- Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, using IFNγ-ELISPOT readout.
- In any HLA-A2+ subjects on the protocol, we may evaluate peripheral blood CD8+ T cell responses against CRC-related peptide epitopes present, using IFN ELISPOT as readout.
Measured: 1 year
May assess the disease-free survival and overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pawel Kalinski
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Pawel Kalinski, University of Pittsburgh
- Investigators
- David L. Bartlett, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671592
- Sponsor's protocol ID
- 10-052
- Other IDs
- R01CA134633
- Status last verified
- Sep 2017
- First submitted
- 20 Aug 2012
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01671592
- Acronym / sponsor ID
- 10-052
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
- Keywords
- Cancer, colorectal, tumor, neoplasms, carcinoma, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Pawel KalinskiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Day 1 MRI with low dose vaccine | Experimental | Biological: DC VaccineDC 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. |
| Day 3 MRI with low dose vaccine | Experimental | Biological: DC VaccineDC 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. |
| Day 1 MRI with high dose vaccine | Experimental | Biological: DC VaccineDC 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. |
| Day 3 MRI with high dose vaccine | Experimental | Biological: DC VaccineDC 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC VaccineAlpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor. | Biological | Day 1 MRI with high dose vaccine, Day 1 MRI with low dose vaccine, Day 3 MRI with high dose vaccine, Day 3 MRI with low dose vaccine |
Primary outcome
Adverse events from the labeled DC vaccine
Time frame: 1 year
Ability to track the labeled DC vaccine by MRI
Time frame: 1 year
2 secondary outcomes
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.
Time frame: 1 year
May assess the disease-free survival and overall survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L. Bartlett, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC Vaccine in people with Colorectal Neoplasms and Colorectal Cancer, run by Pawel Kalinski at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events from the labeled DC vaccine (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.