Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Pharmaceutical / Industry	EPIMMUNE-EP2101-101 USO-02081, UCLA-030106

Objectives

1. Determine the safety and tolerability of EP-2101 peptide vaccine in patients with stage IIB or IIIA non-small cell lung cancer.
2. Determine the frequency of response in patients treated with this vaccine.
3. Determine the breadth of tumor-associated antigen-specific cytotoxic T-lymphocyte (CTL) response in patients treated with this vaccine.
4. Determine the magnitude of each epitope-specific CTL response in patients treated with this vaccine.
5. Determine the overall CTL response for each epitope in patients treated with this vaccine.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer meeting 1 of the following staging criteria:
  • Stage IIB (T2, N1, M0 or T3, N0, M0)
  • Stage IIIA (T1, N2, M0; T2, N2, M0; T3, N1, M0; or T3, N2, M0)



• No evidence of disease after prior standard treatment with curative intent
  • Therapy completed within the past 4 to 12 weeks



• HLA-A2 positive

Prior/Concurrent Therapy:

Biologic therapy

• No prior vaccine therapy for cancer
• More than 1 month since prior interferon therapy
• More than 1 month since prior interleukin therapy
• More than 1 month since prior influenza vaccine
• More than 1 month since other prior immunomodulatory agents
• No other concurrent immunomodulatory agents
• No concurrent influenza vaccine

Chemotherapy

• Not specified

Endocrine therapy

• More than 1 month since prior systemic corticosteroids

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent participation in any other investigational study

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin at least 10 g/dL
• Platelet count greater than 100,000/mm³
• WBC greater than 3,000/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Absolute lymphocyte count greater than 500/mm³

Hepatic

• AST and ALT no greater than 2.5 times upper limit of normal (ULN)
• Bilirubin less than 3 mg/dL
• Alkaline phosphatase no greater than 2.5 times ULN
• No history of hepatitis B or C

Renal

• Creatinine no greater than 1.5 times ULN

Immunologic

• No prior serious adverse reactions, including anaphylaxis and related symptoms such as hives or respiratory difficulty, to any vaccines
• No prior hypersensitivity to any components of the study vaccine
• No history of any of the following conditions:
  • Systemic lupus erythematosus
  • Scleroderma
  • Connective tissue disease
  • Sjögren's syndrome
  • Rheumatoid arthritis
  • Inflammatory bowel disease
• HIV negative

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 weeks after study treatment
• No other prior cancer except successfully excised nonmelanomatous skin cancer or surgically cured carcinoma in situ of the cervix
• No other acute medical condition that would preclude study therapy
• No mental or psychiatric condition that would preclude study compliance

Expected Enrollment

A total of 12-18 patients will be accrued for this study.

Outline

This is an open-label, multicenter study.

Patients receive EP-2101 peptide vaccine emulsified in Montanide ISA-51 subcutaneously every 3 weeks for a total of 6 vaccinations in the absence of unacceptable toxicity.

Patients are followed at 3 weeks.

Trial Contact Information

Trial Lead Organizations

Epimmune Incorporated

Scott Plasman, Protocol chair		Ph: 858-860-2537

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