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Carcinoma, Non-Small-Cell-LungEarly Phase 1NCT02419170

Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)

A Early Phase 1 study testing Apheresis, Cyclophosphamide and Personalized mature dendritic cell vaccine in people with Carcinoma, Non-Small-Cell-Lung and Non-Small Cell Lung Cancer, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this research study is to study the safety and immune response of people who receive a personalized dendritic cell vaccine with the intention of stimulating the immune system to react to lung cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apheresis, Cyclophosphamide and Personalized mature dendritic cell vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2016to Oct 2023
Phase
Early 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

  • Patients with completely resected stage I non-small cell lung cancer who are not considered for adjuvant post operative therapy.
  • Age ≥ 18 years.
  • ECOG performance status 0-1.
  • HLA-A2 positive.
  • Required initial laboratory values (submitted within 14 days prior to registration):
  • WBC > 3,000/mm3
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  • Hg ≥ 9.0 gm/dL
  • Platelets >75,000/mm3
  • Serum bilirubin < 2.0 mg/dL
  • Serum creatinine < 2.0 mg/dL
  • Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.
  • Able to understand and willing to sign an IRB-approved written informed consent document.

Who cannot join

  • Prior treatment with cytotoxic chemotherapy
  • Prior treatment with targeted therapy or immunotherapy.
  • Active untreated CNS metastasis.
  • Active infection.
  • Prior malignancy (except non-melanoma skin cancer) within 3 years.
  • Pregnant or nursing.
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  • Concurrent treatment with systemic corticosteroids; local (inhaled or topical) steroids are permitted.
  • Known allergy to eggs.
  • Prior history or uveitis or autoimmune inflammatory eye disease.
  • Known positivity for hepatitis B sAg, hepatitis C antibody, or HIV antibody.

About this study

The purpose of this research study is to study the safety and immune response of people who receive a personalized dendritic cell vaccine with the intention of stimulating the immune system to react to lung cancer cells.

Read the detailed description

Tumor vaccines represent a promising area of clinical investigation in solid tumors based on evidence of clinical activity and minimal toxicity. The underlying hypothesis of this research is that immunization against tumor neoantigens is effectively required to elicit antigen-reactive T cells capable of recognizing and eliminating cancer. Moreover, both quantitative and qualitative improvements in CD8 immunity are necessary (but not sufficient) for clinical response and improved survival. The goal of this study is to build on our prior clinical trial results in melanoma by studying the immune response to tumor neoantigens in patients with stage 1 NSCLC.

Being tested
Standard of care surgery, Apheresis, Cyclophosphamide, Personalized mature dendritic cell vaccine
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of care surgeryProcedure or surgery

  • ApheresisProcedure or surgery

  • CyclophosphamideDrug

    Also called Cytoxan®

  • Personalized mature dendritic cell vaccineBiological

Study groups in NCT02419170
Study groupRoleWhat they receive
Surgery/Apheresis/Cyclophosphamide/VaccineExperimental* Standard of care surgery * Apheresis (between Day -28 and Day -7) approximately 12 weeks after surgery * Cyclophosphamide 300 mg/m^2 intravenously (Day -4) * Personalized vaccine (Day 1) * Booster dose of personalized vaccine (Day 43) * Booster dose of personalized vaccine (Day 85)
Receives: Procedure: Standard of care surgery; Procedure: Apheresis; Drug: Cyclophosphamide; Biological: Personalized mature dendritic cell vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunological response as measured by increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay

    -Blood for immunological response is drawn every week from Dose #1 to 6 weeks after Dose #3 (Day 1 to Day 126 = Week 18 and then every 4 weeks until Day 365)

    Measured: 1 year

  2. Safety and tolerability of vaccine as measured by adverse events experienced and graded by NCI CTCAE Version 4.0

    Safety will be closely monitored after vaccination. Patients will be observed for 2 hours after the first dose and vital signs recorded every 30 minutes during that time period beginning at the start of the infusion. For each dose thereafter, patients will be observed in the treatment area for 30 minutes after the infusion. The following parameters will be assessed:

    • Local signs and symptoms
    • Systemic signs and symptoms
    • Laboratory evaluations
    • Adverse and serious adverse events
    • Toxicity will be graded according to the NCI's CTCAE version 4.0.

    Measured: 30 days after last vaccine (approximately Day 115)

Secondary outcomes (1)

  1. Time to progression (TTP)

    These patients have been completed resected so there is no tumor response to monitor. CT scans evaluating for progression will be performed at baseline, following the third vaccine dose, and as per routine care during follow-up (generally every 3 months for the first year and every 6 months for the next 4 years thereafter).

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study startJul 2016
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2023 (estimated)

Why it stopped: Investigator who manufactured the vaccine left the university.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02419170
Sponsor's protocol ID
15-x043
Status last verified
Jul 2016
First submitted
4 Feb 2015
Last updated
18 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Apheresis, Cyclophosphamide and Personalized mature dendritic cell vaccine in people with Carcinoma, Non-Small-Cell-Lung and Non-Small Cell Lung Cancer, run by Washington University School of Medicine.

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 12 inclusion and 10 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 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Immunological response as measured by increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay (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?

On the ClinicalTrials.gov record for NCT02419170.

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 18 Jul 2016.

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