Immune Response and Safety of HS110 Vaccine in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01504542 |
Recruitment Status :
Withdrawn
(Lack of enrollment)
First Posted : January 5, 2012
Last Update Posted : November 21, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Biological: HS110 vaccine Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Immune Response, Safety and Efficacy of HS-110 in Combination With Erlotinib vs. Erlotinib as a Single Agent in Patients With Advanced, Non-EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) |
Study Start Date : | December 2011 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Low-dose HS-110
2,000,000 cells/0.5mls + erlotinib 150mg orally once daily
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Biological: HS110 vaccine
0.5ml to be administered twice weekly for 18 weeks (36 doses) |
Experimental: High dose HS110
10,000,000 HS110 cells/0.5ml + erlotinib 150mg orally once daily.
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Biological: HS110 vaccine
0.5 mls to be dosed twice weekly for 18 weeks (36 doses) |
Placebo Comparator: Placebo vaccine + erlotinib 150mg orally once daily
Placebo vaccine buffered saline solution + erlotinib 150mg orally once daily
|
Biological: Placebo
0.5ml buffered saline placebo to be administered twice weekly for 18 weeks (36 doses) |
- Immunologic Response (defined as production of IFNƴ from CD8+ T cells as evaluated by ELISPOT assay) [ Time Frame: Week 18 ]Immune response will be evalulated by ELISPOT assays and change will be assessed from baseline.
- Safety of the combination of HS110 vaccine and erlotinib [ Time Frame: Up to 1 year ]Incidence and severity of adverse events, changes in laboratory measures, physical exams and evaluation of autoimmune phenomena.
- Tumor assessment by immunologic response criteria (irRC) [ Time Frame: Baseline, Week 12 and Week 22 ]Patients will have a CT scan performed at baseline, Week 12 and Week 22 or at the end of study visit in the case of early termination from study. Investigators will assess the disease response using irRC for overall response, CR, PR, SD or PD.
- Exploratory Immunologic endpoint - evaluation of circulating tumor cells [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18 ]Analysis via a semiautomated, epithelial cell adhesion molecule-based immunomagnetic technique.
- Exploratory immunologic endpoint - immune function [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18 ]Analysis of cell surfance molecules by flow cytometry
- Exploratory immunologic endpoint - proteomic profile [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18 ]Examination of protein expression utilizing western blot, immunohistochemical staining, enzyme linked immunosorbent assay (ELISA) or mass spectrometry

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing and able to comply with the protocol and sign informed consent.
- Histologically or cytologically confirmed locally advanced or metastatic squamous cell or non-squamous cell NSCLC after at least one but no more than two prior regimens of approved therapy for their disease (not including adjuvant treatment).
- Confirmation that their disease has no known EGFR mutations based on documented prior analysis or study-specific analysis of archival tumor tissue.
- At least one site of bi-dimensionally measurable NSCLC disease.
- Patients with recurrent, resectable disease able to undergo six weeks of vaccine therapy prior to resection.
- Brain metastasis if present and treated must be stable by CT scn or MRI for at least 8 weeks.
- Age ≥ 18 years.
- EGOG performance status of 0-1.
- Lab parameters
- Albumin ≥ 3.5mg/dL
- Total Bilirubin < 1.5mg/dL
- Alanine transaminase (ALT), and aspartate transaminase(AST)≤ 2.5 x upper limits of normal or ≤ x ULN in case of liver metastases.
- Serum creatinine < 1.5mg/dL or calculated creatinine clearance >50 mL/minute per the Cockcroft-Gault formula.
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White blood cell (WBC) count ≥ 4,000/mm3 with an absolute neutrophil count
- 1,500mm3.
- Hemoglobin ≥ 9g/dL
- Platelet count ≥ 100,000/mm3
- Women of childbearing potential or men of fathering potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide or surgical sterilization) during the study and for 6 months after receiving the last administration of study medication. Female patients of childbearing potential must test negative for pregnancy prior to enrolling in the trial. Post-menopausal (cessation of menses for more than 6 months) women are eligible for this study.
Exclusion Criteria:
- No prior therapy with EGFR-targeted drugs, including approved and investigational therapies, or prior immunologic or biologic response modifier therapy for treatment of their disease.
- Uncontrolled or untreated brain or spinal cord metastases or meningeal carcinomatosis.
- Known human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy.
- Autoimmunity syndromes (primary or acquired) including, but not limited to, the following: rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, or glomerulonephritis requiring active steroid or other immunosuppressive therapy.
- Known immunodeficiency disorders, either primary or acquired.
- Other malignancies present within the past 3 years, except for cutaneous basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
- History of clinically significant cardiac impairment, congestive heart failure > New York Heart Association (NYHA) cardiac disease classification Class II, unstable angina, or myocardial infarction during the previous 6 months, or serious cardiac arrhythmia.
- Known alcohol or chemical abuse, or mental or psychiatric condition precluding compliance with the protocol.
- Chemotherapy, radiation, or other antitumor therapy during the last 4 weeks.
- Pregnant, nursing, or planning a pregnancy (both men and women) within 12 months of enrollment.
- Known allergy to soy or egg products.
- Patient is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

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): NCT01504542
United States, Texas | |
Mary Crowley Cancer Research Centers | |
Dallas, Texas, United States, 75201 |
Principal Investigator: | John Nemunaitis, MD | Mary Crowley Cancer Research Centers |
Responsible Party: | Heat Biologics |
ClinicalTrials.gov Identifier: | NCT01504542 |
Other Study ID Numbers: |
HS110-10-01 |
First Posted: | January 5, 2012 Key Record Dates |
Last Update Posted: | November 21, 2013 |
Last Verified: | November 2013 |
Immunotherapy |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Vaccines Immunologic Factors Physiological Effects of Drugs |