Clinical trial · Interventional
Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
A Phase II Study Of Aerosolized GM-CSF In The Treatment Of Metastatic Renal Cell Carcinoma To The Lung
NCT00006483CI-TRIAL-00023017completedPhase 2ClinicalTrials.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: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may be an effective treatment for patients with kidney cancer that has spread to the lung. PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who have kidney cancer that has spread to the lung.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- aerosolized sargramostim
- description
- Patients receive aerosolized sargramostim (GM-CSF) by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21. Treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity. Patients are followed for disease progression and then every 3 months thereafter.
- interventionNames
- Biological: sargramostim
Primary outcomes (1)
- measure
- Determine the 4-month progression-free survival rate
- timeFrame
- 4 months
Secondary outcomes (1)
- measure
- Determine the 4-month overall survival rate
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma for which no known standard therapy that is potentially curative or capable of extending life expectancy exists (e.g., surgery) * Measurable metastatic disease in the lung * At least one unidimensionally measurable lesion at least 20 mm by conventional techniques * No CNS metastases that require treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin greater than 8.0 g/dL Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal * Creatinine no greater than 2.5 times ULN Pulmonary * No hemoptysis of grade 3 or greater * No reactive airway disease on active therapy Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No other metastatic malignancy within the past 3 years except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior immunotherapy * More than 2 weeks since other prior biologic therapy Chemotherapy * More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) Endocrine therapy * More than 2 weeks since prior corticosteroids * No concurrent systemic glucocorticoids Radiotherapy * More than 2 weeks since prior radiotherapy * No prior radiotherapy to more than 10% of total lung volume in the radiation field Other * At least 4 weeks since prior bronchodialators * No concurrent immunosuppressive agents
References
Publications (0)
Data not yet available
No reference posted for this study.