Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: Lung Cancer

Treatments: Biological: ras peptide cancer vaccine; Biological: sargramostim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00005630

NCI-G00-1775

CDR0000067783 (Registry Identifier)

99-028

Details and patient eligibility

About

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy and sargramostim in treating patients who have non-small cell lung cancer.

Full description

OBJECTIVES:

• Determine whether a specific T-cell response can be induced in patients with stage IB-IV non-small cell lung cancer treated with mutant K-ras peptide vaccine (limited to the specific K-ras peptide mutation in their tumors) and sargramostim (GM-CSF).
• Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive sargramostim (GM-CSF) intradermally (ID) on days 1-10 beginning a maximum of 6 months after complete surgical resection. Patients receive mutant K-ras peptide vaccine (limited to the specific K-ras mutation in their tumors) ID on day 7. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 and 12 weeks.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 18 months.

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage IB-IV non-small cell lung cancer

  • Non-squamous cell histology only
  • Must have undergone curative surgery within the past 6 months and must be free of recurrence
  • Tumor must demonstrate a specific K-ras mutation at codon 12 for which a vaccine preparation is available

PATIENT CHARACTERISTICS:

Age:

• Over 17

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No New York Heart Association class III or IV heart disease

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No concurrent medical condition that would preclude compliance or immunologic response to study treatment
• No other serious concurrent medical condition
• No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the uterine cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since prior postoperative chemotherapy and recovered

Endocrine therapy:

• No concurrent systemic steroids
• Concurrent inhaled steroids allowed

Radiotherapy:

• No prior radiotherapy to spleen
• At least 3 weeks since prior postoperative radiotherapy and recovered

Surgery:

• See Disease Characteristics
• No prior splenectomy

Other:

• No concurrent immunosuppressive drugs or antiinflammatory drugs