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

This study has been completed.
Information provided by:
Memorial Sloan-Kettering Cancer Center Identifier:
First received: May 2, 2000
Last updated: June 18, 2013
Last verified: June 2013

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.

Condition Intervention Phase
Lung Cancer
Biological: ras peptide cancer vaccine
Biological: sargramostim
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: July 1999
Study Completion Date: May 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • Over 17

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


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


  • Not specified


  • Not specified


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


  • 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


Biologic therapy:

  • Not specified


  • At least 3 weeks since prior postoperative chemotherapy and recovered

Endocrine therapy:

  • No concurrent systemic steroids
  • Concurrent inhaled steroids allowed


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


  • See Disease Characteristics
  • No prior splenectomy


  • No concurrent immunosuppressive drugs or antiinflammatory drugs
  Contacts and Locations
Please refer to this study by its identifier: NCT00005630

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Study Chair: Lee M. Krug, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00005630     History of Changes
Other Study ID Numbers: 99-028, CDR0000067783, NCI-G00-1775
Study First Received: May 2, 2000
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on April 17, 2014