CompletedNCT01671592Updated Sep 26, 2017

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

A Phase 1 interventional study of DC Vaccine in Colorectal Neoplasms, Colorectal Cancer and Colorectal Carcinoma, sponsored by Pawel Kalinski. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-26.

Sponsored by Pawel Kalinski · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 6
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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

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 studied

Colorectal Neoplasms
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal

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Keywords

Cancer
colorectal
tumor
neoplasms
carcinoma
vaccine

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Pawel Kalinski is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 6 participants (actual)

Study arms

Experimental
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.
Biological: DC Vaccine
Experimental
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.
Biological: DC Vaccine
Experimental
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.
Biological: DC Vaccine
Experimental
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.
Biological: DC Vaccine

Interventions

BiologicalDC Vaccine
Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.

What researchers measure

Primary outcomes

Adverse events from the labeled DC vaccine
Time frame: 1 year
Ability to track the labeled DC vaccine by MRI
Time frame: 1 year

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.
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.
Time frame: 1 year
May assess the disease-free survival and overall survival
Time frame: 5 years

Study locations

1 site

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01671592
Lead sponsor: Pawel Kalinski
Collaborators: National Cancer Institute (NCI)
Responsible party: Pawel Kalinski (Professor of Surgery, University of Pittsburgh) — Sponsor-investigator
First posted: Aug 23, 2012
Start date: Jan 2013
Primary completion: Apr 2014
Completion: Apr 2014
Last update: Sep 26, 2017

Study contacts

David L. Bartlett, MD

principal investigator · University of Pittsburgh

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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