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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

May 2, 2000
June 18, 2013
July 1999
May 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005630 on Archive Site
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Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial

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.


  • 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.

Phase 1
Primary Purpose: Treatment
Lung Cancer
  • Biological: ras peptide cancer vaccine
  • Biological: sargramostim
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2002
May 2002   (final data collection date for primary outcome measure)


  • 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
17 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
99-028, CDR0000067783, NCI-G00-1775
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Lee M. Krug, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP