Status:
COMPLETED
Lung Cancer Vaccine Plus Oral Dietary Supplement
Lead Sponsor:
Edward Hirschowitz
Collaborating Sponsors:
University of Louisville
Conditions:
Lung Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE1
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 medicatio...
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 defin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01829373
Start Date
October 1 2011
End Date
February 1 2013
Last Update
April 11 2013
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536