Lung Cancer Vaccine Plus Oral Dietary Supplement

NCT01829373 | Completed Phase 1 DMC

• 1 other identifier: BG1006
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

lung cancer

Outcome Measures

Primary Outcomes (1)

• Immunologic response to vaccine

  Increase in number of peripheral blood T cells recognizing cancer antigens

  12 months

Study Arms (1)

Vaccine plus oral beta glucan

EXPERIMENTAL

Vaccine plus oral beta glucan

Biological: vaccine 1650-G

Interventions

vaccine 1650-G BIOLOGICAL

Also known as: Beta Glucan capsule

Vaccine plus oral beta glucan

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Edward Hirschowitz: lead
• University of Louisville: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (3)

• Hirschowitz EA, Mullins A, Prajapati D, Baeker T, Kloecker G, Foody T, Damron K, Love C, Yannelli JR. Pilot study of 1650-G: a simplified cellular vaccine for lung cancer. J Thorac Oncol. 2011 Jan;6(1):169-73. doi: 10.1097/JTO.0b013e3181fb5c22.

  PMID: 21150468 BACKGROUND

• Hirschowitz EA, Foody T, Hidalgo GE, Yannelli JR. Immunization of NSCLC patients with antigen-pulsed immature autologous dendritic cells. Lung Cancer. 2007 Sep;57(3):365-72. doi: 10.1016/j.lungcan.2007.04.002. Epub 2007 May 16.

  PMID: 17509725 BACKGROUND

• Hirschowitz EA, Foody T, Kryscio R, Dickson L, Sturgill J, Yannelli J. Autologous dendritic cell vaccines for non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2808-15. doi: 10.1200/JCO.2004.01.074.

  PMID: 15254048 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Vaccines; beta-Glucans

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Edward Hirschowitz, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• John Yannelli, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: February 1, 2013
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

US (1)