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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United States

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.

  1. Comparison of overall survival with historical controls

  2. Safety

Secondary outcomes (2)
  1. Progression-free survival

  2. 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.

  1. First posted4 Mar 2005 (estimated)
  2. Study startDec 2004

Resources

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)
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

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.

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