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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00516685
Recruitment Status : Terminated (Due to inability of patient enrollment, decision taken to terminate in the interests of patients and later Malaysia is incorporated into global Phase 3 trial.)
First Posted : August 15, 2007
Last Update Posted : September 30, 2011
Information provided by:
Bioven Sdn. Bhd.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV Biological: Recombinant Human rEGF-P64K/Montanide Vaccine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
No Intervention: Control Group
Patients in this arm will only receive Best Supportive Care.

Primary Outcome Measures :
  1. Survival [ Time Frame: Two and a half years ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00516685

Local Institution
Kubang Kerian, Kelantan, Malaysia, 16150
Local Institution
Nilai, Negeri Sembilan, Malaysia, 71800
Local Institution
Kuantan, Pahang, Malaysia, 25100
Local Institution
Georgetown, Pulau Pinang, Malaysia, 11200
Local Institution
Kota Kinabalu, Sabah, Malaysia, 88838
Local Institution
Kota Kinabalu, Sabah, Malaysia, 88996
Local Institution
Klang, Selangor, Malaysia, 41000
Local Institution
Petaling Jaya, Selangor, Malaysia, 50603
Local Institution
Kuala Lumpur, Malaysia, 51900
Local Institution
Kuala Lumpur, Malaysia, 53000
Sponsors and Collaborators
Bioven Sdn. Bhd.

Responsible Party: DR G SELVARATNAM, NILAI CANCER INSTITUTE Identifier: NCT00516685     History of Changes
Other Study ID Numbers: CT 07-03
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: September 30, 2011
Last Verified: September 2011

Keywords provided by Bioven Sdn. Bhd.:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs