Lung Cancer Vaccine Plus Oral Dietary Supplement

Phase 1

Completed

• Conditions: Lung Cancer
• Interventions: Biological: vaccine 1650-G

• Registration Number: NCT01829373
• Lead Sponsor: Edward Hirschowitz

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.

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 Timeline

• Study Start: 2011-10
• Primary Completion: 2012-06
• Study Completion: 2013-02
• Status Verified: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-10
• Last Update Submitted: 2013-04-10
• Study First Posted: 2013-04-11
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine plus oral beta glucan	vaccine 1650-G	Vaccine plus oral beta glucan

Primary Outcome Measures

Name	Time	Method
Immunologic response to vaccine	12 months	Increase in number of peripheral blood T cells recognizing cancer antigens

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States