Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
This study has been 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.)
Sponsor:
Bioven Sdn. Bhd.
Information provided by:
Bioven Sdn. Bhd.
ClinicalTrials.gov Identifier:
NCT00516685
First received: August 14, 2007
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
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 |
|---|---|---|
|
Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV |
Biological: Recombinant Human rEGF-P64K/Montanide Vaccine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Bioven Sdn. Bhd.:
Primary Outcome Measures:
- Survival [ Time Frame: Two and a half years ] [ Designated as safety issue: No ]
Secondary Outcome 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 230 |
| Study Start Date: | July 2007 |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516685
Locations
| Malaysia | |
| 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, 88996 | |
| Local Institution | |
| Kota Kinabalu, Sabah, Malaysia, 88838 | |
| 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.
Investigators
| Principal Investigator: | G SELVARATNAM, MD | NILAI CANCER INSTITUTE |
More Information
No publications provided
| Responsible Party: | DR G SELVARATNAM, NILAI CANCER INSTITUTE |
| ClinicalTrials.gov Identifier: | NCT00516685 History of Changes |
| Other Study ID Numbers: | CT 07-03 |
| Study First Received: | August 14, 2007 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Malaysia: Ministry of Health |
Keywords provided by Bioven Sdn. Bhd.:
|
LUNG CANCER NSCLC EGF CANCER VACCINE IMMUNOTHERAPY |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013