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Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Resectable Non-Small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Cyclin B1 Peptide

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring early stage non-small cell lung cancer, non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have histologically or cytologically confirmed non-small cell lung cancer
All patients must have one of the following stages: Stage IA(T1NO), and IB T2NO), II & IIIA (N2 negative)
No prior chemotherapy or radiation therapy for non-small cell lung cancer
Age >18 years
ECOG performance status <2
Patients must have acceptable organ and marrow
Patient must be deemed surgically and medically resectable
Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients may not be receiving any other investigational agents.
Patients should not have received chemotherapy or radiotherapy within 3 months prior to entry to study.
Patients with tumors involving the superior sulcus are not eligible.
Patients must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test.
Known HIV-positive patients are excluded from the study.
Patients with a history of known autoimmune disease are excluded from this study.

Sites / Locations

Outcomes

Primary Outcome Measures

Evaluate the ability of cyclin B1 peptide pulsed autologous dendritic cell vaccine to induce an immune response.

Secondary Outcome Measures

Full Information

NCT ID

NCT01398124

First Posted

July 19, 2011

Last Updated

August 21, 2017

Sponsor

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01398124

Brief Title

Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Resectable Non-Small Cell Lung Cancer

Official Title

A Pilot Study of Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Patients With Resectable Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Withdrawn

Why Stopped

We will not be pursuing this study.

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Despite recent advances in the treatment of patients with resected NSCLC, disease recurrence and mortality related to lung cancer are common among patients with early stage non-small cell lung cancer (NSCLC). Therefore novel approaches are necessary to improve the outcome for early stage NSCLC. The preclinical studies conducted with vaccine based approaches provide the rationale to evaluate this as an adjunct to surgery for patients with early stage NSCLC. Administration of the vaccine before surgery will also allow for the evaluation of the tumor specimen for immunological responses to the vaccine.

Detailed Description

In the currently proposed study, patients will receive the first dose of the vaccine approximately 2 weeks prior to surgery. The second dose will be administered about 3-4 weeks following surgery. A booster dose of the vaccine will be given 6 months after the 2nd vaccine. The tumor tissue and serum will be studied for immunological responses following therapy with the vaccine. Patients are allowed to receive adjuvant chemotherapy if indicated. The choice of the chemotherapy regimen will be at the discretion of the treating physician, preferably 3-4 cycles of platinum combination regimen. The vaccine should be administered at least 2 weeks before chemotherapy is initiated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

early stage non-small cell lung cancer, non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Cyclin B1 Peptide

Intervention Description

vaccine

Primary Outcome Measure Information:

Title

Evaluate the ability of cyclin B1 peptide pulsed autologous dendritic cell vaccine to induce an immune response.

Time Frame

One week after second vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically or cytologically confirmed non-small cell lung cancer All patients must have one of the following stages: Stage IA(T1NO), and IB T2NO), II & IIIA (N2 negative) No prior chemotherapy or radiation therapy for non-small cell lung cancer Age >18 years ECOG performance status <2 Patients must have acceptable organ and marrow Patient must be deemed surgically and medically resectable Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients may not be receiving any other investigational agents. Patients should not have received chemotherapy or radiotherapy within 3 months prior to entry to study. Patients with tumors involving the superior sulcus are not eligible. Patients must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test. Known HIV-positive patients are excluded from the study. Patients with a history of known autoimmune disease are excluded from this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chandra P. Belani, MD

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Resectable Non-Small Cell Lung Cancer

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