Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
NCT ID: NCT00516685
Last Updated: 2011-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
230 participants
INTERVENTIONAL
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Recombinant Human rEGF-P64K/Montanide Vaccine
Control Group
Patients in this arm will only receive Best Supportive Care.
No interventions assigned to this group
Interventions
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Recombinant Human rEGF-P64K/Montanide Vaccine
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Bioven Sdn. Bhd.
INDUSTRY
Responsible Party
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NILAI CANCER INSTITUTE
Principal Investigators
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G SELVARATNAM, MD
Role: PRINCIPAL_INVESTIGATOR
NILAI CANCER INSTITUTE
Locations
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Local Institution
Kubang Kerian, Kelantan, Malaysia
Local Institution
Kampung Baharu Nilai, Negeri Sembilan, Malaysia
Local Institution
Kuantan, Pahang, Malaysia
Local Institution
George Town, Pulau Pinang, Malaysia
Local Institution
Kota Kinabalu, Sabah, Malaysia
Local Institution
Kota Kinabalu, Sabah, Malaysia
Local Institution
Klang, Selangor, Malaysia
Local Institution
Petaling Jaya, Selangor, Malaysia
Local Institution
Kuala Lumpur, , Malaysia
Local Institution
Kuala Lumpur, , Malaysia
Countries
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Other Identifiers
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CT 07-03
Identifier Type: -
Identifier Source: org_study_id