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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial |
| Study Start Date: | July 1999 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically proven stage IB-IV non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | |||||
| New York, New York, United States, 10021 | |||||
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Lee M. Krug, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| 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 |
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