Immune Response and Safety of HS110 Vaccine in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

NCT01504542 | Withdrawn Phase 2 DMC

• 1 other identifier: HS110-10-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll patients with locally advanced or metastatic non-EGFR mutated Non-Small Cell Lung Cancer (NSCLC) lung cancer after failure of at least one but no more than two prior approved treatment regimens. Patients will be randomized to receive one of two doses of vaccine or placebo to be dosed twice weekly for 18 weeks (36 doses total) and patients will also receive erlotinib 150mg taken orally once daily for the duration of the trial. The study will examine the immune effects, safety and efficacy of two different doses of HS110 vaccine in combination with erlotinib versus erlotinib alone.

Conditions

Non-small Cell Lung Cancer

Keywords

Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Immunologic Response (defined as production of IFNƴ from CD8+ T cells as evaluated by ELISPOT assay)

  Immune response will be evalulated by ELISPOT assays and change will be assessed from baseline.

  Week 18

Secondary Outcomes (5)

• Safety of the combination of HS110 vaccine and erlotinib

  Up to 1 year

• Tumor assessment by immunologic response criteria (irRC)

  Baseline, Week 12 and Week 22

• Exploratory Immunologic endpoint - evaluation of circulating tumor cells

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18

• Exploratory immunologic endpoint - immune function

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18

• Exploratory immunologic endpoint - proteomic profile

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18

Study Arms (3)

Low-dose HS-110

EXPERIMENTAL

2,000,000 cells/0.5mls + erlotinib 150mg orally once daily

Biological: HS110 vaccine

High dose HS110

EXPERIMENTAL

10,000,000 HS110 cells/0.5ml + erlotinib 150mg orally once daily.

Biological: HS110 vaccine

Placebo vaccine + erlotinib 150mg orally once daily

PLACEBO COMPARATOR

Placebo vaccine buffered saline solution + erlotinib 150mg orally once daily

Biological: Placebo

Interventions

HS110 vaccine BIOLOGICAL

0.5ml to be administered twice weekly for 18 weeks (36 doses)

Low-dose HS-110

Placebo BIOLOGICAL

0.5ml buffered saline placebo to be administered twice weekly for 18 weeks (36 doses)

Placebo vaccine + erlotinib 150mg orally once daily

Eligibility Criteria

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

You may qualify if:

• 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.
• White blood cell (WBC) count ≥ 4,000/mm3 with an absolute neutrophil count
• ,500mm3.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heat Biologics: lead

Study Sites (1)

Mary Crowley Cancer Research Centers

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• John Nemunaitis, MD

  Mary Crowley Cancer Research Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 5, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

US (1)