Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial
17 Years
N/A
Both
Lung Cancer
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 Center | New York, New York 10021 |
