Lung Cancer Vaccine Plus Oral Dietary Supplement
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|ClinicalTrials.gov Identifier: NCT01829373|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: vaccine 1650-G||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lung Cancer Immunotherapy With Vaccine 1650-G and Yeast Derived β-Glucan|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||February 2013|
Experimental: Vaccine plus oral beta glucan
Vaccine plus oral beta glucan
Biological: vaccine 1650-G
Other Name: Beta Glucan capsule
- Immunologic response to vaccine [ Time Frame: 12 months ]Increase in number of peripheral blood T cells recognizing cancer antigens
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829373
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Edward Hirschowitz, MD||University of Kentucky|
|Principal Investigator:||John Yannelli, PhD||University of Kentucky|
|Responsible Party:||Edward Hirschowitz, Associate Professor, University of Kentucky|
|Other Study ID Numbers:||
|First Posted:||April 11, 2013 Key Record Dates|
|Last Update Posted:||April 11, 2013|
|Last Verified:||April 2013|
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases