NCT02419170

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Longer than P75 for early_phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

3.3 years

First QC Date

February 4, 2015

Last Update Submit

July 14, 2016

Conditions

Carcinoma, Non-Small-Cell-LungNonsmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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)

    1 year

  • 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.

    30 days after last vaccine (approximately Day 115)

Secondary Outcomes (1)

  • Time to progression (TTP)

    5 years

Study Arms (1)

Surgery/Apheresis/Cyclophosphamide/Vaccine

EXPERIMENTAL

* 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)

Procedure: Standard of care surgeryProcedure: ApheresisDrug: CyclophosphamideBiological: Personalized mature dendritic cell vaccine

Interventions

Standard of care surgeryPROCEDURE
Surgery/Apheresis/Cyclophosphamide/Vaccine
ApheresisPROCEDURE
Surgery/Apheresis/Cyclophosphamide/Vaccine
CyclophosphamideDRUG
Also known as: Cytoxan®
Surgery/Apheresis/Cyclophosphamide/Vaccine
Personalized mature dendritic cell vaccineBIOLOGICAL
Surgery/Apheresis/Cyclophosphamide/Vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Component RemovalCyclophosphamide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Ramaswamy Govindan, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

April 17, 2015

Study Start

July 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2023

Last Updated

July 18, 2016

Record last verified: 2016-07