A Randomized Trial to Study the Safety and Efficacy of EGF Cancer Vaccination in Late-stage (IIIB/IV) Non-small Cell Lung Cancer Patients

NCT01444118 | Terminated Phase 3 DMC

• 1 other identifier: BV-NSCLC-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The vaccine contains humanized recombinant antigen (Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase III clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase III trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IIIB/IV NSCLC patients compared to standard treatment and supportive care.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Each patient will be followed till death occurs within the time frame of study of 3 years

Secondary Outcomes (1)

• To establish the safety of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients.

  Each patients will be followed till death occurs within the time frame of study of 3 years

Study Arms (2)

EGF Vaccine

EXPERIMENTAL

Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.

Biological: Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)

Best Supportive Care

NO INTERVENTION

Patients in this arm will receive best supportive care

Interventions

Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine) BIOLOGICAL

Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.

EGF Vaccine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are aged 20-65 years (inclusive).
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Have adequate bone marrow, liver and renal function, as assessed by the Investigator. A sample taken at Screening should confirm that:
• White blood cell (WBC) count ≥ 3000 per µL
• Platelet count ≥ 100,000 per µL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN when liver metastases are present)
• Total bilirubin ≤ 1.5 x ULN
• Serum creatinine ≤ 1.5 x ULN
• Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced, inoperable disease (Stage IIIb or Stage IV \[as defined by the American Joint Committee on Cancer staging system\]), excluding brain metastases.
• Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy or consolidation radiotherapy).
• Agree to use double-barrier contraception (males and females alike \[if applicable\]). A negative pregnancy test must be documented at Screening for females of childbearing potential.
• Note: Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile, while post-menopausal refers to those women with at least 2 years from last menstruation.
• Have signed a voluntary written informed consent form (ICF). Patients should be cooperative, willing and able to participate and adhere to the Protocol requirements, including their availability for the follow-up.

You may not qualify if:

• Patient has no measurable disease (as defined by RECIST criteria, version 1.1).
• Patient is a candidate for concurrent chemo-radiotherapy or post chemo thoracic radiotherapy.
• Patient has a history of known or suspected central nervous system (CNS) metastases.
• Patient has a history of primary malignancy (except resected non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix), unless in complete remission and off all chemotherapy and/or radiotherapy for that disease for a minimum of 5 years.
• Patient is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc. Use is not permitted within 1 month before Screening.
• Patient is taking any other immunotherapy.
• Patient has primary or secondary immunodeficiencies (e.g. documented Human Immunodeficiency Virus \[HIV\]).
• Patient has autoimmune disease.
• Patient has undergone splenectomy.
• Patient is taking oral, intramuscular or intravenous corticosteroids. Use is not permitted within 1 month before Screening. Inhaled corticosteroids to treat respiratory insufficiency (e.g. chronic obstructive pulmonary disease \[COPD\]), or topical steroids are permitted.
• Patient has a neurotoxicity (Grade ≥2).
• Patient has diarrhoea (Grade ≥2).
• Patient has received other vaccines (with the exception of the influenza vaccine), within 1 month before Screening.
• Patient has a history of any severe or life-threatening hypersensitivity reaction.
• Patient has an unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease).

Sponsors & Collaborators

• Bioven Europe: lead

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Marianne Nicolson, Dr.

  Aberdeen Royal Infirmary UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: September 30, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

GB (1)