Lung CancerPhase 2NCT00089726
A Cancer Vaccine (CG8123) Given With and Without Cyclophosphamide for Advanced Stage Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing CG8123 and Cyclophosphamide in people with Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by Cell Genesys.
Trial summary
The main purpose of this research study is to determine if a vaccine made from a patient's lung cancer tumor cells will be effective in making the cancer shrink or disappear. The vaccine will be given by itself to some patients, while other patients will get the vaccine with cyclophosphamide (a type of chemotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- CG8123 and Cyclophosphamide
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Jan 2006
- Phase
- Phase 2
- 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
- 18 years or older
- Suspicious diagnosis of or histologically- confirmed stage IIIB or IV non small-cell lung cancer
- Accessible and adequate tumor source for vaccine production.
- Tumor source for vaccine production must be accessible by a minor surgical procedure performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or malignant pleural effusion)
- Measurable disease to evaluate following tumor procurement
- Limited metastatic tumor burden
- Life expectancy at least 4 months
- ECOG Performance Status 0 - 1
Who cannot join
- Active and/or untreated brain metastases
- Active or impending spinal cord compression
- Active auto-immune disease or treatment with immunosuppressants
- Decompensated congestive heart failure or recent significant cardiac event
- Coexisting malignancies
- Significant or uncontrolled medical problems or laboratory abnormalities that might increase the risk of surgical complications or vaccine treatment
- Previous treatment with gene therapy (including any adenoviral-based therapy)
About this study
Official title: A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) With and Without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer
The main purpose of this research study is to determine if a vaccine made from a patient's lung cancer tumor cells will be effective in making the cancer shrink or disappear. The vaccine will be given by itself to some patients, while other patients will get the vaccine with cyclophosphamide (a type of chemotherapy). Studies in animals and other cancer vaccine trials suggest that cyclophosphamide may make tumor vaccines more potent. This study will try to determine if vaccine given with or without this chemotherapy is effective in destroying lung cancer cells. Additionally, the study will collect information on vaccine safety, both with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms (e.g., shortness of breath).
Tumors from surgical resection will be processed and made into a vaccine. Prior to treatment, patients will be randomized equally to one of two treatment groups, Cohort A and Cohort B. Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day prior to the first, third, and fifth vaccine treatments. Patients will receive intradermal (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of up to five vaccine treatments. The duration of this study, including active follow up, is approximately two years. After this, patients will be followed-up yearly for a total of 15 years.
- Conditions
- Lung Cancer, Carcinoma, Non-Small-Cell Lung
- Being tested
- CG8123, Cyclophosphamide
- Keywords
- cancer vaccine, NSCLC, immunotherapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG8123Biological
CyclophosphamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2004 (estimated)
- Study startMar 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Cell Genesys
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089726
- Sponsor's protocol ID
- D-0031
- Status last verified
- Dec 2007
- First submitted
- 11 Aug 2004
- Last updated
- 24 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) With and Without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00089726
- Acronym / sponsor ID
- D-0031
- Conditions
- Lung Cancer, Carcinoma, Non-Small-Cell Lung
- Keywords
- cancer vaccine, NSCLC, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Cell GenesysIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Jan 2006 (actual)
- First posted
- 12 Aug 2004 (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 main purpose of this research study is to determine if a vaccine made from a patient's lung cancer tumor cells will be effective in making the cancer shrink or disappear. The vaccine will be given by itself to some patients, while other patients will get the vaccine with cyclophosphamide (a type of chemotherapy). Studies in animals and other cancer vaccine trials suggest that cyclophosphamide may make tumor vaccines more potent. This study will try to determine if vaccine given with or without this chemotherapy is effective in destroying lung cancer cells. Additionally, the study will collect information on vaccine safety, both with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms (e.g., shortness of breath).
Tumors from surgical resection will be processed and made into a vaccine. Prior to treatment, patients will be randomized equally to one of two treatment groups, Cohort A and Cohort B. Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day prior to the first, third, and fifth vaccine treatments. Patients will receive intradermal (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of up to five vaccine treatments. The duration of this study, including active follow up, is approximately two years. After this, patients will be followed-up yearly for a total of 15 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years or older
- Suspicious diagnosis of or histologically- confirmed stage IIIB or IV non small-cell lung cancer
- Accessible and adequate tumor source for vaccine production.
- Tumor source for vaccine production must be accessible by a minor surgical procedure performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or malignant pleural effusion)
- Measurable disease to evaluate following tumor procurement
Key exclusion criteria (7 listed)
- Active and/or untreated brain metastases
- Active or impending spinal cord compression
- Active auto-immune disease or treatment with immunosuppressants
- Decompensated congestive heart failure or recent significant cardiac event
- Coexisting malignancies
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 |
|---|---|---|
| CG8123 | Biological | – |
| Cyclophosphamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2007.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CG8123 and Cyclophosphamide in people with Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by Cell Genesys.
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 7 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: finished, as of the sponsor's last update on 24 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 24 Dec 2007.