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Sponsored by: |
Bioven Sdn. Bhd. |
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Information provided by: | Bioven Sdn. Bhd. |
ClinicalTrials.gov Identifier: | NCT00516685 |
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 | Intervention | Phase |
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Non-Small-Cell Lung Cancer (NSCLC) Stage IIIb/IV |
Biological: Recombinant Human rEGF-P64K/Montanide Vaccine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 230 |
Study Start Date: | July 2007 |
Arms | Assigned Interventions |
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Vaccine Group: 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.
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Biological: Recombinant Human rEGF-P64K/Montanide Vaccine |
Control Group: No Intervention
Patients in this arm will only receive Best Supportive Care.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: (CRC) Clinical Research Centre, Malaysia | (603)2692 4249 | contact@crc.gov.my |
Malaysia | |
Local Institution | Recruiting |
Kuala Lumpur, Malaysia, 51900 | |
Local Institution | Recruiting |
Kuala Lumpur, Malaysia, 53000 | |
Malaysia, Kelantan | |
Local Institution | Recruiting |
Kubang Kerian, Kelantan, Malaysia, 16150 | |
Malaysia, Negeri Sembilan | |
Local Institution | Recruiting |
Nilai, Negeri Sembilan, Malaysia, 71800 | |
Malaysia, Pahang | |
Local Institution | Recruiting |
Kuantan, Pahang, Malaysia, 25100 | |
Malaysia, Pulau Pinang | |
Local Institution | Recruiting |
Georgetown, Pulau Pinang, Malaysia, 11200 | |
Malaysia, Sabah | |
Local Institution | Recruiting |
Kota Kinabalu, Sabah, Malaysia, 88996 | |
Local Institution | Recruiting |
Kota Kinabalu, Sabah, Malaysia, 88838 | |
Malaysia, Selangor | |
Local Institution | Recruiting |
Klang, Selangor, Malaysia, 41000 | |
Local Institution | Recruiting |
Petaling Jaya, Selangor, Malaysia, 50603 |
Principal Investigator: | G SELVARATNAM, MD | NILAI CANCER INSTITUTE |
Responsible Party: | NILAI CANCER INSTITUTE ( DR G SELVARATNAM ) |
Study ID Numbers: | CT 07-03 |
Study First Received: | August 14, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00516685 History of Changes |
Health Authority: | Malaysia: Ministry of Health |
LUNG CANCER NSCLC EGF CANCER VACCINE IMMUNOTHERAPY |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |