Clinical trial · Interventional
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
NCT00005630CI-TRIAL-00010799completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ras peptide cancer vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.