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Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial


Phase 1
17 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lee M. Krug, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-028

NCT ID:

NCT00005630

Start Date:

July 1999

Completion Date:

May 2002

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021