Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IVPhase 2/3NSCLCNCT00516685
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
A Phase 2/3 study testing Recombinant Human rEGF-P64K/Montanide Vaccine in people with Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV, run by Bioven Sdn. Bhd. at 10 sites in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
- What is being tested?
- Recombinant Human rEGF-P64K/Montanide Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 10 sitesMalaysia
- Study dates
- Jul 2007to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
Malaysia10 sites
Local Institution
George Town, Pulau Pinang, 11200
Local Institution
Kampung Baharu Nilai, Negeri Sembilan, 71800
Local Institution
Klang, Selangor, 41000
Local Institution
Kota Kinabalu, Sabah, 88838
Local Institution
Kota Kinabalu, Sabah, 88996
Local Institution
Kuala Lumpur, 51900
Local Institution
Kuala Lumpur, 53000
Local Institution
Kuantan, Pahang, 25100
Local Institution
Kubang Kerian, Kelantan, 16150
Local Institution
Petaling Jaya, Selangor, 50603
About this 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
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).
- Being tested
- Recombinant Human rEGF-P64K/Montanide Vaccine
- Keywords
- LUNG CANCER, NSCLC, EGF, CANCER VACCINE, IMMUNOTHERAPY
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human rEGF-P64K/Montanide VaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Recombinant Human rEGF-P64K/Montanide Vaccine |
| Control Group | No intervention | Patients in this arm will only receive Best Supportive Care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Two and a half years
Secondary outcomes (1)
Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life
Measured: Two and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJul 2007
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioven Sdn. Bhd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- G SELVARATNAM, MD, Principal investigator, NILAI CANCER INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516685
- Sponsor's protocol ID
- CT 07-03
- Acronym
- NSCLC
- Status last verified
- Sep 2011
- First submitted
- 14 Aug 2007
- Last updated
- 30 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00516685
- Acronym / sponsor ID
- NSCLC / CT 07-03
- Keywords
- LUNG CANCER, NSCLC, EGF, CANCER VACCINE, IMMUNOTHERAPY
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Bioven Sdn. Bhd.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Group | Experimental | Biological: Recombinant Human rEGF-P64K/Montanide VaccinePatients 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. |
| Control Group | No intervention | –Patients in this arm will only receive Best Supportive Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human rEGF-P64K/Montanide Vaccine | Biological | Vaccine Group |
Primary outcome
Survival
Time frame: Two and a half years
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G SELVARATNAM, MD principal investigator
NILAI CANCER INSTITUTE
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Recombinant Human rEGF-P64K/Montanide Vaccine in people with Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV, run by Bioven Sdn. Bhd. at 10 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Two and a half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2011.