Metastatic Colorectal CancerPhase 2NCT02615574
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
A Phase 2 study testing αDC1 vaccine and CKM in people with Metastatic Colorectal Cancer, run by Pawel Kalinski at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- αDC1 vaccine and CKM
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2018
- Phase
- Phase 2
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- αDC1 vaccine, CKM
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
αDC1 vaccineBiological
Also called alpha-type-1-polarized dendritic cell vaccine
Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
CKMDrug
Also called celecoxib (Celebrex®), Interferon-α2b (IFN), rintatolimod (Ampligen®)
Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
| Study group | Role | What they receive |
|---|---|---|
| αDC1 vaccine + CKM | Experimental | all subjects enrolled in study Receives: Biological: αDC1 vaccine; Drug: CKM |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: up to 36 months
Secondary outcomes (2)
immune-related Overall Response Rate (irORR)
Measured: up to 36 months
immune-related Progression-Free Survival (irPFS)
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Due to inadequate supply of drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pawel Kalinski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pawel Kalinski, University of Pittsburgh
- Investigators
- James J Lee, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615574
- Sponsor's protocol ID
- 15-023
- Status last verified
- Sep 2017
- First submitted
- 24 Nov 2015
- 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
- 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
- ClinicalTrials.gov ID
- NCT02615574
- Acronym / sponsor ID
- 15-023
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to inadequate supply of drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pawel KalinskiUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Nov 2015 (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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| αDC1 vaccine + CKM | Experimental | Biological: αDC1 vaccine, Drug: CKMall subjects enrolled in study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| αDC1 vaccineAlso: alpha-type-1-polarized dendritic cell vaccineSubjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM. | Biological | αDC1 vaccine + CKM |
| CKMAlso: celecoxib (Celebrex®), Interferon-α2b (IFN), rintatolimod (Ampligen®)Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM. | Drug | αDC1 vaccine + CKM |
Primary outcome
overall survival
Time frame: up to 36 months
2 secondary outcomes
immune-related Overall Response Rate (irORR)
Time frame: up to 36 months
immune-related Progression-Free Survival (irPFS)
Time frame: up to 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
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CRC
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.
James J Lee, MD, PhD 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 2 study testing αDC1 vaccine and CKM in people with Metastatic 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 15 inclusion and 17 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: withdrawn, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
overall survival (time frame: up to 36 months). 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.