Lung CancerPhase 2NCT00104780
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Phase 2 study testing EP-2101 and incomplete Freund's adjuvant in people with Lung Cancer, run by Epimmune at 9 sites in United States.
Trial summary
RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EP-2101 and incomplete Freund's adjuvant
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Dec 2004to not given
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:
- Stage IIIB disease
- Stage IV disease
- Recurrent disease
- HLA-A2-positive disease
- HLA-A2 negative patients are eligible to enroll in group II (observation) only
- Measurable disease
- Estimated tumor volume ≤ 125 cc
- No CNS signs or symptoms of brain metastases
- Brain metastases that are clinically stable for ≥ 2 months AND do not require anticonvulsants or systemic steroids are allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 12 weeks
Hematopoietic
- Hemoglobin ≥ 10 g/dL
- Platelet count > 100,000/mm^3
- WBC > 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Absolute lymphocyte count > 500/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver involvement by tumor)
- Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL for patients with liver involvement by tumor)
- Albumin ≥ 2.5 g/dL
- Alkaline phosphatase ≤ 2.5 times ULN
- No history of hepatitis B or C positivity
Renal
- Creatinine ≤ 2 times ULN
Immunologic
- No history of any of the following active conditions:
- Systemic lupus erythematosus
- Scleroderma
- Connective tissue disease
- Sjögren's syndrome
- Multiple sclerosis
- Rheumatoid arthritis
- Inflammatory bowel disease
- No history of HIV positivity
- No history of serious adverse reaction, including anaphylaxis, or hypersensitivity to study vaccine or to any of its components
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 weeks after completion of study treatment
- No other malignancy within the past 5 years except curatively excised nonmelanoma skin cancer or surgically cured carcinoma in situ of the cervix
- No other acute medical condition that would preclude study treatment
- No mental or psychiatric condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 1 month since prior interferon therapy
- More than 1 month since prior interleukin therapy
- No prior cancer vaccine therapy, including participation in a vaccine study
Chemotherapy
- At least 4 weeks since prior chemotherapy
Endocrine therapy
- See Disease Characteristics
- More than 1 month since prior systemic corticosteroids except stable doses of inhaled corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- No concurrent participation in another investigational study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New York Oncology Hematology, P. C. at Albany Regional Cancer Care
Albany, New York, 12208
Mary Crowley Medical Research Center at Sammons Cancer Center
Dallas, Texas, 75246
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, 29615
Dayton Oncology & Hematology, P.A. - Kettering
Kettering, Ohio, 45409
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, 37203
Cancer Centers of Florida - Ocoee
Ocoee, Florida, 34761
Cancer Care Northwest - North
Spokane, Washington, 99218
Tyler Cancer Center
Tyler, Texas, 75702
About this study
Official title: A Phase II, Open Label, Multi-center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the overall survival of patients with HLA-A2-positive, stage IIIB or IV or recurrent non-small cell lung cancer (NSCLC) treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative, stage IIIB or IV or recurrent NSCLC who undergo observation only.
- Determine the safety of this vaccine in these patients.
Secondary
- Determine progression-free survival of patients treated with this vaccine.
- Determine the frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine.
OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status.
- Group I (HLA-A2 positive): Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15.
- Group II (HLA-A2 negative): Patients undergo observation in weeks 9 and 18. After completion of study treatment, patients in group I are followed at 3 weeks. All patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
- Conditions
- Lung Cancer
- Being tested
- EP-2101, incomplete Freund's adjuvant
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- 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.
EP-2101Biological
incomplete Freund's adjuvantBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of overall survival with historical controls
Safety
Secondary outcomes (2)
Progression-free survival
Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2005 (estimated)
- Study startDec 2004
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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Epimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Plasman, Study chair, Epimmune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104780
- Sponsor's protocol ID
- CDR0000415721
- Other IDs
- EPIMMUNE-EP2101-201, MCMRC-0461
- Status last verified
- Mar 2006
- First submitted
- 3 Mar 2005
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Multi-center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00104780
- Acronym / sponsor ID
- CDR0000415721
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- EpimmuneIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- First posted
- 4 Mar 2005 (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.
RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the overall survival of patients with HLA-A2-positive, stage IIIB or IV or recurrent non-small cell lung cancer (NSCLC) treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative, stage IIIB or IV or recurrent NSCLC who undergo observation only.
- Determine the safety of this vaccine in these patients.
Secondary
- Determine progression-free survival of patients treated with this vaccine.
- Determine the frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine.
OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status.
- Group I (HLA-A2 positive): Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15.
- Group II (HLA-A2 negative): Patients undergo observation in weeks 9 and 18. After completion of study treatment, patients in group I are followed at 3 weeks. All patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EP-2101 | Biological | – |
| incomplete Freund's adjuvant | Biological | – |
Primary outcome
Comparison of overall survival with historical controls
Safety
2 secondary outcomes
Progression-free survival
Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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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.
Scott Plasman study chair
Epimmune
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EP-2101 and incomplete Freund's adjuvant in people with Lung Cancer, run by Epimmune at 9 sites 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?
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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
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?
Comparison of overall survival with historical controls. The study lists 2 primary outcomes in all. 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 6 Nov 2013.