Small Cell Lung CancerPhase 2NCT00776295
Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
A Phase 2 study testing Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes in people with Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis.
- Measurable disease at the time of initial therapy
- Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy.
- Responsive disease to standard chemoradiation therapy as defined by RECIST
- Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation
- CBC with an absolute neutrophil count (ANC) >/= 1,000/uL, hemoglobin >/= 8.0 g/DL and platelet count >/= 75,000/uL.
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- Normal prothrombin time (PT) and partial thromboplastin time (aPTT), unless on monitored anticoagulation therapy for medical conditions not excluded in the trial.
- Liver enzymes: total bilirubin less than or equal to 2mg/dL; AST and ALT less than 1.5X the upper limit of normal.
- Creatinine clearance of >/= 60 mL/min
- Pulmonary: DLCO greater than 50%
- Cardiac: left ventricular ejection fraction greater than 45%
Who cannot join
- Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation
- Pregnant or lactating woman
- HIV infection confirmed by NAT
- Common variable immunodeficiency
- Active CNS malignancy
- Active bacterial, fungal or viral infection
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- Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care
- Prior history of autologous or allogeneic hematopoietic cell transplantation
- Presence of protocol specific comorbid conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Autologous Peripheral Blood Hematopoietic Cell Transplantation (PBHCT) Followed by Dendritic Cell p53 Vaccination and Adoptive T Cell Transfer in Patients With Limited Stage Small Cell Lung Cancer
The purpose of this study is to determine whether p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
- Keywords
- Small Cell Lung Cancer, SCLC, Limited Stage Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytesBiological
Autologous Dendritic Cells Derived from Peripheral Blood Mononuclear Cells, Cultured with Granulocyte-Macrophage Colony-Stimulating Factor and Interleukin 4, Transfected with Adenovirus Vector (Ad5CMV-p53, Introgen Therapeutics) Expressing Wildtype p53 Gene; Combined with Autologous Expanded T Lymphocytes (CD3+, CD4+, and CD8+), Cultured with OKT3 (Orthoclone) and Anti-CD28 (Repligen) Coated Magnetic Beads
| Study group | Role | What they receive |
|---|---|---|
| adeno virus vectored p53 | Experimental | Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes Receives: Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Meeting 1-year Overall Survival
Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death
Measured: up to one year
Secondary outcomes (1)
3 Year Progression-free Survival
3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startMay 2007
- Primary completionJun 2010
- Study completionAug 2010
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Kharfan-Dabaja, MD, Principal investigator, H. Lee Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776295
- Sponsor's protocol ID
- MCC 14955
- Status last verified
- Jan 2013
- First submitted
- 20 Oct 2008
- Last updated
- 24 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Autologous Peripheral Blood Hematopoietic Cell Transplantation (PBHCT) Followed by Dendritic Cell p53 Vaccination and Adoptive T Cell Transfer in Patients With Limited Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00776295
- Acronym / sponsor ID
- MCC 14955
- Conditions
- Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer, SCLC, Limited Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Posted 21 Jun 2012
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 p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adeno virus vectored p53 | Experimental | Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytesCombined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis.
- Measurable disease at the time of initial therapy
- Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy.
- Responsive disease to standard chemoradiation therapy as defined by RECIST
- Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation
Key exclusion criteria (9 listed)
- Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation
- Pregnant or lactating woman
- HIV infection confirmed by NAT
- Common variable immunodeficiency
- Active CNS malignancy
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 |
|---|---|---|
| Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytesAutologous Dendritic Cells Derived from Peripheral Blood Mononuclear Cells, Cultured with Granulocyte-Macrophage Colony-Stimulating Factor and Interleukin 4, Transfected with Adenovirus Vector (Ad5CMV-p53, Introgen Therapeutics) Expressing Wildtype p53 Gene; Combined with Autologous Expanded T Lymphocytes (CD3+, CD4+, and CD8+), Cultured with OKT3 (Orthoclone) and Anti-CD28 (Repligen) Coated Magnetic Beads | Biological | adeno virus vectored p53 |
Primary outcome
Number of Subjects Meeting 1-year Overall Survival
Time frame: up to one year
Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death
1 secondary outcome
3 Year Progression-free Survival
Time frame: up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- H. Lee Moffitt Cancer Center \& Research InstituteLink 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.
Mohamed Kharfan-Dabaja, MD principal investigator
H. Lee Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes in people with Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 11 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 24 Jan 2013. 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 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?
Yes. Results are posted in the registry (first posted 21 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Meeting 1-year Overall Survival (time frame: up to one year). 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 24 Jan 2013.