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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

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)


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of overall survival with historical controls

Safety Issue:

No

Principal Investigator

Scott Plasman

Investigator Role:

Study Chair

Investigator Affiliation:

Epimmune

Authority:

United States: Federal Government

Study ID:

CDR0000415721

NCT ID:

NCT00104780

Start Date:

December 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Sarah Cannon Cancer Center at Centennial Medical CenterNashville, Tennessee  37203
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
Tyler Cancer CenterTyler, Texas  75702
Mary Crowley Medical Research Center at Sammons Cancer CenterDallas, Texas  75246
Cancer Care Northwest - NorthSpokane, Washington  99218
Cancer Centers of Florida - OcoeeOcoee, Florida  34761
New York Oncology Hematology, P. C. at Albany Regional Cancer CareAlbany, New York  12208
Dayton Oncology & Hematology, P.A. - KetteringKettering, Ohio  45409