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Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III, Phase II | Treatment | Active | 18 and over | CT 07-03
NCT00516685 |
Trial Description
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). Eligibility Criteria 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.
- 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.
Trial Contact Information
Trial Lead Organizations/Sponsors Bioven Sdn. Bhd. | G SELVARATNAM, MD | | Principal Investigator |
Trial Sites
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| Malaysia |
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Georgetown |
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| | | | | | | | Local Institution |
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Klang |
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| | | Local Institution |
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Kota Kinabalu |
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| | | Local Institution |
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Kuala Lumpur |
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| | | Local Institution |
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Kuantan |
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| | | Local Institution |
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Kubang Kerian |
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| | | Local Institution |
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Nilai |
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| | | Local Institution |
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Petaling Jaya |
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| | | Local Institution |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00516685
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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