A Study of Type-1 Polarized Dendritic Cell (αDC1) Vaccine in Combination With Tumor-Selective Chemokine Modulation (Interferon-α2b, Rintatolimod, and Celecoxib) in Subjects With Chemo-Refractory Metastatic Colorectal Cancer
NCT ID: NCT02615574
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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αDC1 vaccine + CKM
all subjects enrolled in study
αDC1 vaccine
Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
CKM
Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
Interventions
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αDC1 vaccine
Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
CKM
Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be able to understand and be willing to sign a written informed consent document.
* Be HLA-A2 positive.
* Have mCRC that has been treated with currently approved standard therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
* Have at least 1 of the tumor sites that must be amenable to core needle biopsy and this may not be the site of disease used to measure antitumor response.
* Have measurable disease based on irRC.
* Have a performance status of ECOG 0 or 1.Have normal organ and marrow function as defined below:
* Platelet ≥ 75,000/µL
* Hemoglobin ≥ 9.0 g/dL
* Absolute Neutrophil Count (ANC) ≥ 1500/µL
* Creatinine \< 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels greater than 1.5 x ULN
* Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
* AST(SGOT) and ALT(SGPT) ≤ 2.5 x institutional upper limit of normal (ULN) OR
≤ 5 x ULN for subjects with liver metastases
* Serum amylase and lipase within normal limits.
Exclusion Criteria
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has active autoimmune disease or history of transplantation.
* Is a woman of child bearing potential (WOCBP) who are pregnant or nursing.
* Has a history of cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent. Subjects with a New York Heart Association classification of III or IV.
* Has a history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years. Subjects with ulceration, bleeding or perforation in the lower bowel are not excluded.
* Has prior allergic reaction or hypersensitivity to celecoxib, or NSAIDs.
* Has an active infection requiring systemic therapy.
* Has significant ascites or pleural effusion requiring drainage for symptom relief.
* Has a known history of Human Immunodeficiency Virus (HIV).
* Has known active Hepatitis B or Hepatitis C infection.
* Has history of asthma, or other allergic-type reactions after taking aspirin or other NSAIDs.
* Has known serious hypersensitivity reactions to peg-interferon alfa-2b or interferon alfa-2b.
* Has autoimmune hepatitis.
* Has hepatic decompensation (Child-Pugh score \> 6; = class B and C).
18 Years
ALL
No
Sponsors
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Pawel Kalinski
OTHER
Responsible Party
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Pawel Kalinski
Professor of Surgery
Principal Investigators
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James J Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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15-023
Identifier Type: -
Identifier Source: org_study_id