Non Small Cell Lung CancerPhase 1DRibbleNCT00850785
Autologous Tumor DRibble Vaccine in Patients With Non-Small Cell Lung Cancer
A Phase 1 study testing DRibble vaccine in people with Non Small Cell Lung Cancer, run by Providence Health & Services at 1 site in United States.
Trial summary
This is a pilot single institution study of DRibble vaccination + GM-CSF in patients with stage IIIB or IV NSCLC who have undergone 0-1 chemotherapy regimens for metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- DRibble vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2012
- Phase
- Phase 1
- 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
- Stage IIIB or IV NSCLC.
- Adequate pleural effusion (>600 cc) or subcutaneous metastases (>1 cc) for
- DRibble vaccine production.
- Measurable or evaluable disease.
- No or one prior chemotherapy regimen for advanced NSCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
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- Age > 18 years.
- CD4 count > 200 per cc.
- Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the toxicities that docetaxel may have on the forming fetus, spermatogenesis or the nursing child.
- Also, because pregnancy may alter immune function it may limit the treatment efficacy.
- Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
- Anticipated lifespan minimum 6 months.
Who cannot join
- Prior vaccine or gene therapy for cancer.
- Untreated brain metastases or spinal cord compression.
- Active autoimmune disease.
- Active other malignancy.
- Known hypersensitivity to docetaxel.
- HIV positive and/or Hepatitis B or C positive.
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- Patients receiving any other concurrent investigational treatment.
- Other medical or psychiatric conditions that in the opinion of the Principal
- Investigator would preclude safe participation in protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: A Pilot Study of Autologous Tumor DRibble Vaccine With Docetaxel in Stage IIIB and IV Non-Small Cell Lung Cancer
This is a pilot single institution study of DRibble vaccination + GM-CSF in patients with stage IIIB or IV NSCLC who have undergone 0-1 chemotherapy regimens for metastatic disease. The primary objective of this trial is to evaluate immune responses induced by autologous DRibble vaccine in vivo and in vitro and against autologous and allogeneic lung cancer cells.
Read the detailed description
Ten patients will be enrolled. Study treatment is as follows: Docetaxel 75 mg/m2 will be given on day 1. Intradermal vaccinations of DRibbles from 5-20 x 106 cell equivalents per vaccine will begin 14 days after docetaxel. Immediately following vaccination, subcutaneous infusion of GM-CSF (50 micrograms/24 hrs) will be initiated. GM-CSF will be infused into the vaccination site for 6 days using the CADD-MS 3 pump.
A second docetaxel injection will be given at day 29 followed by a second vaccination 14 days later and 3 additional vaccines will be given at 2-week intervals. Following each vaccination, GM-CSF will again be infused over 6 days via the CADD-MS 3 pump.
Peripheral blood will be obtained for immune monitoring at each vaccination. DTH to autologous tumor and to DRibble vaccine will be tested before the first and fifth vaccines. A second leukapheresis for immune monitoring will be obtained at 12 weeks. Clinical tumor response will be assessed after the fifth vaccination unless clinical evidence of tumor progression occurs sooner.
Immune response will be assessed by DTH, T-cell function, T-cell migration into the vaccine sites and cytokine release assays. Sophisticated flow cytometry assays will be used to detect active T-cell subsets. Safety will be monitored by physical and laboratory exams at each vaccine visit and adverse events will be recorded and reported as appropriate. Clinical response will be assessed by tumor measurements by CT scan and/or physical exam at study entry and after 12 weeks. PFS and OS will be recorded.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- DRibble vaccine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRibble vaccineBiological
Docetaxel 75 mg/m2 will be administered in the several days after leukapheresis. Intradermal (ID) vaccine injections of DRibbles made from at least 5 million and up to 20 million cell equivalents per vaccination will begin 14 days after the first docetaxel. Each DRibble vaccine will be followed by the 6-day infusion of GM-CSF via the CADD-MS 3 pump (50 micrograms/24 hrs).
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine-induced immune response as measured by in vitro immune monitoring and by the delayed-type hypersensitivity (DTH) testing to injections of autologous, unmodified tumor cells and to DRibbles.
Measured: DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine.
Secondary outcomes (1)
Tumor response (RECIST criteria)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- The Wayne D. Kuni and Joan E. Kuni Foundation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Walter J Urba, MD, PhD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850785
- Sponsor's protocol ID
- 06-76
- Other IDs
- 1R21CA123864-01A2
- Acronym
- DRibble
- Status last verified
- Sep 2016
- First submitted
- 23 Feb 2009
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sanborn RE, Ross HJ, Aung S, Acheson A, Moudgil T, Puri S, Hilton T, Fisher B, Coffey T, Paustian C, Neuberger M, Walker E, Hu HM, Urba WJ, Fox BA. A pilot study of an autologous tumor-derived autophagosome vaccine with docetaxel in patients with stage IV non-small cell lung cancer. J Immunother Cancer. 2017 Dec 19;5(1):103. doi: 10.1186/s40425-017-0306-6.
PubMed 29258618
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Autologous Tumor DRibble Vaccine With Docetaxel in Stage IIIB and IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00850785
- Acronym / sponsor ID
- DRibble / 06-76
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- The Wayne D. Kuni and Joan E. Kuni Foundation, National Cancer Institute (NCI)
- Study start
- Jan 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Feb 2009 (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.
This is a pilot single institution study of DRibble vaccination + GM-CSF in patients with stage IIIB or IV NSCLC who have undergone 0-1 chemotherapy regimens for metastatic disease. The primary objective of this trial is to evaluate immune responses induced by autologous DRibble vaccine in vivo and in vitro and against autologous and allogeneic lung cancer cells.
Detailed description
Ten patients will be enrolled. Study treatment is as follows: Docetaxel 75 mg/m2 will be given on day 1. Intradermal vaccinations of DRibbles from 5-20 x 106 cell equivalents per vaccine will begin 14 days after docetaxel. Immediately following vaccination, subcutaneous infusion of GM-CSF (50 micrograms/24 hrs) will be initiated. GM-CSF will be infused into the vaccination site for 6 days using the CADD-MS 3 pump.
A second docetaxel injection will be given at day 29 followed by a second vaccination 14 days later and 3 additional vaccines will be given at 2-week intervals. Following each vaccination, GM-CSF will again be infused over 6 days via the CADD-MS 3 pump.
Peripheral blood will be obtained for immune monitoring at each vaccination. DTH to autologous tumor and to DRibble vaccine will be tested before the first and fifth vaccines. A second leukapheresis for immune monitoring will be obtained at 12 weeks. Clinical tumor response will be assessed after the fifth vaccination unless clinical evidence of tumor progression occurs sooner.
Immune response will be assessed by DTH, T-cell function, T-cell migration into the vaccine sites and cytokine release assays. Sophisticated flow cytometry assays will be used to detect active T-cell subsets. Safety will be monitored by physical and laboratory exams at each vaccine visit and adverse events will be recorded and reported as appropriate. Clinical response will be assessed by tumor measurements by CT scan and/or physical exam at study entry and after 12 weeks. PFS and OS will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (12 listed)
- Stage IIIB or IV NSCLC.
- Adequate pleural effusion (>600 cc) or subcutaneous metastases (>1 cc) for
- DRibble vaccine production.
- Measurable or evaluable disease.
- No or one prior chemotherapy regimen for advanced NSCLC.
Key exclusion criteria (9 listed)
- Prior vaccine or gene therapy for cancer.
- Untreated brain metastases or spinal cord compression.
- Active autoimmune disease.
- Active other malignancy.
- Known hypersensitivity to docetaxel.
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 |
|---|---|---|
| DRibble vaccineDocetaxel 75 mg/m2 will be administered in the several days after leukapheresis. Intradermal (ID) vaccine injections of DRibbles made from at least 5 million and up to 20 million cell equivalents per vaccination will begin 14 days after the first docetaxel. Each DRibble vaccine will be followed by the 6-day infusion of GM-CSF via the CADD-MS 3 pump (50 micrograms/24 hrs). | Biological | – |
Primary outcome
Vaccine-induced immune response as measured by in vitro immune monitoring and by the delayed-type hypersensitivity (DTH) testing to injections of autologous, unmodified tumor cells and to DRibbles.
Time frame: DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine.
1 secondary outcome
Tumor response (RECIST criteria)
Time frame: Week 12
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 27 Sep 2016.
- Derived from this study: PubMed 29258618Sanborn RE, Ross HJ, Aung S, Acheson A, Moudgil T, Puri S, Hilton T, Fisher B, Coffey T, Paustian C, Neuberger M, Walker E, Hu HM, Urba WJ, Fox BA. A pilot study of an autologous tumor-derived autophagosome vaccine with docetaxel in patients with stage IV non-small cell lung cancer. J Immunother Cancer. 2017 Dec 19;5(1):103. doi: 10.1186/s40425-017-0306-6.
- Individual participant dataSharing planned: No
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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.
Walter J Urba, MD, PhD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DRibble vaccine in people with Non Small Cell Lung Cancer, run by Providence Health & Services at 1 site in United States.
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 12 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: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Vaccine-induced immune response as measured by in vitro immune monitoring and by the delayed-type hypersensitivity (DTH) testing to injections of autologous, unmodified tumor cells and to DRibbles. (time frame: DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850785, which also lists 1 linked publication.
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 27 Sep 2016.