Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV

Official Title: “A Phase II/III Trial to Assess the Safety, Immunogenicity and Preliminary Efficacy of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine Administered to Patients With Non-Small-Cell Lung Cancer (NSCLC) After Receiving Conventional First Line Chemotherapy”

The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV non-small-cell lung cancer (NSCLC).

Intervention(s) in this Clinical Trial

• Biological: Recombinant Human rEGF-P64K/Montanide Vaccine

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Vaccine Group
  • 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.
• No Intervention: Control Group
  • Patients in this arm will only receive Best Supportive Care.

Primary Measures

• Survival
  • Time Frame: Two and a half years
    Safety Issue?: No

Secondary Measures

• Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life
  • Time Frame: Two and a half years
    Safety Issue?: No

Inclusion Criteria:

• Patients who have signed the informed consent form.
• Patients who are eighteen years of age or over with histologically or cytologically confirmed NSCLC in advanced stages IIIb or IV, not amenable to any attempt of curative chemo-radiotherapy and/or surgery.
• Patients with measurable lesions, defined as those measurable at least in one dimension (refered to higher diameter) and with a diameter equal or higher 20 mm using conventional techniques (PET, CT scan, MRI, Rx) or equal or higher 10 mm using
• CT scan.
• Patients who have finished their last cycle of chemotherapy and/or radiotherapy not less than 4 weeks prior to randomization and not more than 8 weeks.
• Female patients of reproductive potential must have negative pregnancy tests. Those female volunteers admitted to the study must be using a reliable means of contraception such as tubal ligation, oral contraceptive or IUD.
• ECOG status 0 to 2.
• Patients with normal organ and bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range.
• Patients with no evidence of objective disease progression, 1 month after finishing first line chemotherapy as per RECIST.

Exclusion Criteria:

• Patients who are candidates for combined modality treatment.
• Patients who are receiving immunosuppressive therapy including corticosteroids.
• Patients who have received immunotherapy within the previous 3 months.
• Patients who have participated in a clinical study within the previous 30 days.
• Patients who may be allergic to any component of the vaccine.
• Medical reasons considered by the investigators as disqualification from the study such as significant uncontrolled co-morbid disease or potential non-compliance with the protocol.
• Patients bearing brain metastasis from the primary lung tumor.
• Patients bearing a second primary tumor.
• Patients showing progressive disease after finishing first line chemotherapy.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bioven Sdn. Bhd. Industry

Overall Clinical Trial Officials and Contacts

G SELVARATNAM, MD Principal Investigator NILAI CANCER INSTITUTE  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00516685

Study ID Number: CT 07-03

ClinicalTrials.gov Identifier: NCT00516685

Health Authority: Malaysia: Ministry of Health