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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

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ClinicalTrials.gov Identifier: NCT02615574
Recruitment Status : Withdrawn (Due to inadequate supply of drug)
First Posted : November 26, 2015
Last Update Posted : September 26, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The investigators hypothesize that the treatment of metastatic colorectal cancer (mCRC) patients with the combination of alpha-type-1-polarized dendritic cell (αDC1) vaccines and tumor-selective chemokine modulation (CKM) will promote the infiltration of vaccination-induced CD8+ CTLs to tumor lesions and subsequently tumor regression with improved patient survival.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Biological: αDC1 vaccine Drug: CKM Phase 2

Detailed Description:
Metastatic colorectal cancer is a major health concern in the United States, and the second leading cause of death due to cancer. The purpose of this trial is to see if the combination of the study vaccine and drugs in patients with this disease can prevent the growth of cancer and prevent new tumors from growing. The study drugs are a combination of celecoxib (Celebrex®), Interferon-α2b (IFN), and rintatolimod (Ampligen®), or CKM.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 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
Study Start Date : March 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: αDC1 vaccine + CKM
all subjects enrolled in study
Biological: αDC1 vaccine
Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
Other Name: alpha-type-1-polarized dendritic cell vaccine
Drug: CKM
Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
Other Names:
  • celecoxib (Celebrex®)
  • Interferon-α2b (IFN)
  • rintatolimod (Ampligen®)

Outcome Measures

Primary Outcome Measures :
  1. overall survival [ Time Frame: up to 36 months ]

Secondary Outcome Measures :
  1. immune-related Overall Response Rate (irORR) [ Time Frame: up to 36 months ]
  2. immune-related Progression-Free Survival (irPFS) [ Time Frame: up to 36 months ]

Other Outcome Measures:
  1. Changes of CD8+ tumor infiltrating lymphocytes (CTLs) [ Time Frame: up to 4 months ]
    Changes in CD8+ CTLs in paired tumor tissues collected at pre- and post-treatment.

  2. Changes of tumor microenvironment [ Time Frame: up to 4 months ]
    Changes of tumor microenvironment in paired tumor tissues collected at pre- and post-treatment.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be age equal to 18 years or older.
  • 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:

  • Is currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment.
  • 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).
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615574

United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Pawel Kalinski
Principal Investigator: James J Lee, MD, PhD University of Pittsburgh
More Information

Responsible Party: Pawel Kalinski, Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02615574     History of Changes
Other Study ID Numbers: 15-023
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Poly I-C
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents