Lung Cancer Vaccine Plus Oral Dietary Supplement

April 10, 2013 updated by: Edward Hirschowitz

Lung Cancer Immunotherapy With Vaccine 1650-G and Yeast Derived β-Glucan

This study tests the ability of the allogeneic cellular vaccine 1650-G vaccine to enhance immune recognition of tumor cells in patients with lung cancer. The vaccine is combined with an oral medication called beta glucan, an over the counter oral dietary supplement that may also stimulate the immune system in ways that helps the body eradicate cancer cells and reduce risk of recurrent cancer. The primary purpose of this study is to measure the changes in the number of immune cells that might help lower risk of cancer recurrence. The investigators do not yet know if the vaccine is effective in fighting cancer and will not know at the end of this study whether this has been of benefit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-label pilot (Phase II) study to assess the immunologic activity of a cellular vaccine composed of killed allogeneic tumor cells (1650-G) and GM-CSF in patients with stage I-IIIA NSCLC after definitive therapy. (Surgery, Surgery plus Radiation Therapy, or Surgery, Radiation Therapy plus Adjuvant Chemotherapy).

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven, surgically resected stage I-IIIA NSCLC (Bronchoalveolar carcinomas are eligible).
  • Must have read, voiced understanding of and signed an informed consent document.
  • At least 21 years old
  • At least 4 weeks but no more than 12 months post surgical resection.
  • At least 4 weeks since completion of chemotherapy or radiation therapy (adjuvant)
  • No evidence of disease following definitive initial therapy evidenced by a CXR, CT or PET scan within 6 weeks of accrual.
  • ECOG performance status of 0 to 2 (Section 19.1)
  • Adequate organ and marrow function defined as follows:
  • Hemoglobin ≥9.0 gm/dL
  • Absolute neutrophil count (ANC) ≥1,500/mcl
  • Platelet count ≥ 75,000/mcl
  • AST <2.5 x upper limit of normal
  • ALT <2.5 x upper limit of normal
  • Creatinine Clearance (CCr) >50 ml/min
  • Female patients must not be pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test and agree to use acceptable birth control until the "analysis for immunologic response" 16 weeks after the second vaccination. Study doctor will discuss acceptable methods of contraception with patients.

Exclusion Criteria:

  • Patients must not have not have no active residual or progressive lung cancer (Stable Disease)
  • History of other malignancies unless they have had curative treatment completed greater than (≥) five years prior to enrollment or one of the following; appropriately managed Carcinoma in situ, basal cell carcinoma of the skin or non-metastatic squamous cell carcinoma of the skin.
  • Patients must not be chronically immunosuppressed.
  • Patients with HIV and other immunosuppressive disorders and patient who chronically use immunosuppressive medications are excluded. Patients should not be taking immuno-suppressive steroids for at least 4 weeks prior to enrollment
  • Individuals with conditions that might require shorter courses of immunosuppressive oral medications (e.g. steroids) during the initial 16 weeks following immunization are excluded.
  • Patients should not have taken or plan to take other immunologically active agents (eg flu vaccines) for a twelve week period, beginning 2 weeks prior to first dose of beta-glucan and two weeks following last dose of beta glucan.
  • Patients must not have a known history of infectious hepatitis.
  • Because of the unknown effects of this treatment on the fetus pregnant females, and childbearing females and males not willing to use contraception are not eligible.
  • Patients must not have cardiovascular disease defined as:
  • New York Heart Association Class III or IV congestive heart failure
  • hemodynamically significant valvular heart disease
  • myocardial infarction within the last six months
  • active angina pectoris
  • uncontrolled ventricular arrhythmias
  • stroke within one year
  • known cerebrovascular disease
  • Patients may not have received any other investigational agents or participated in any investigational drug study within 4 weeks preceding initiation of study treatment.
  • No known allergies or history of allergic reactions to any colony stimulating factor (GCSF, GMCSF)
  • No known intolerance to yeast derive β-glucan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vaccine plus oral beta glucan
Biological: vaccine 1650-G
Other Names:
  • Beta Glucan capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunologic response to vaccine
Time Frame: 12 months
Increase in number of peripheral blood T cells recognizing cancer antigens
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward Hirschowitz

Collaborators

University of Louisville

Investigators

  • Principal Investigator: Edward Hirschowitz, MD, University of Kentucky
  • Principal Investigator: John Yannelli, PhD, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (ESTIMATE)

April 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BG1006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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