Back to resultsMature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)
Primary Purpose
Carcinoma, Non-Small-Cell-Lung, Non-Small Cell Lung Cancer, Nonsmall Cell Lung Cancer
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Standard of care surgery
Apheresis
Cyclophosphamide
Personalized mature dendritic cell vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell-Lung
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery/Apheresis/Cyclophosphamide/Vaccine
Arm Description
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)
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02419170
First Posted
February 4, 2015
Last Updated
July 14, 2016
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02419170
Brief Title
Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)
Official Title
Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator who manufactured the vaccine left the university.
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell-Lung, Non-Small Cell Lung Cancer, Nonsmall Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery/Apheresis/Cyclophosphamide/Vaccine
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Standard of care surgery
Intervention Type
Procedure
Intervention Name(s)
Apheresis
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan®
Intervention Type
Biological
Intervention Name(s)
Personalized mature dendritic cell vaccine
Primary Outcome Measure Information:
Title
Immunological response as measured by increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay
Description
-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)
Time Frame
1 year
Title
Safety and tolerability of vaccine as measured by adverse events experienced and graded by NCI CTCAE Version 4.0
Description
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.
Time Frame
30 days after last vaccine (approximately Day 115)
Secondary Outcome Measure Information:
Title
Time to progression (TTP)
Description
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).
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramaswamy Govindan, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)
We'll reach out to this number within 24 hrs