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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	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	Biological: ras peptide cancer vaccine Biological: sargramostim	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

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

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000067783, MSKCC-99028, NCI-G00-1775
Study First Received:	May 2, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00005630 History of Changes
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

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009