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

This study has been completed.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005630
  Purpose

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
Drug: ras peptide cancer vaccine
Drug: sargramostim
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Sargramostim    Granulocyte-macrophage colony-stimulating factor   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 1999

Detailed 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.

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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005630

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Lee M. Krug, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067783, MSKCC-99028, NCI-G00-1775
First Received:   May 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005630
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on December 03, 2008




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