Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Study Details
Study Description
Brief Summary
RATIONALE: Colony-stimulating factors, such as sargramostim, may help the body's immune system to kill cancer cells. Giving sargramostim in different ways may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of sargramostim given as a breathing treatment for treating patients who have melanoma that is metastatic to the lung.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES: I. Determine the therapeutic effects of aerosolized sargramostim (GM-CSF) in terms of progression free survival at 2 months and median survival rate in patients with metastatic melanoma to the lung. II. Determine the immunomodulatory effects of this treatment regimen in this patient population. III. Assess the quality of life in terms of physical and personal concerns of these patients treated with this regimen.
OUTLINE: Patients receive aerosolized sargramostim (GM-CSF) over 10-15 minutes twice daily for 7 days. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to course 5. Patients are followed every 2 months for at least 1.5 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: sargramostim Patients receive aerosolized sargramostim (GM-CSF) over 10-15 minutes twice daily for 7 days. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to course 5. Patients are followed every 2 months for at least 1.5 years. |
Biological: sargramostim
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival [2 months]
- Median survival [Up to 1.5 years]
Secondary Outcome Measures
- Quality of life [Up to 1.5 years]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed melanoma with radiographic evidence of prior or active involvement of the lung or pleura Measurable disease At least one lesion with at least one dimension in diameter of at least 10 mm on CT scan or MRI No non-measurable disease including the following: Bone lesions Leptomeningeal disease Ascites Pleural or pericardial effusion Inflammatory breast disease Lymphangitis cutis or pulmonis Unconfirmed abdominal masses not followed by imaging Cystic lesions
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/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 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 Cardiovascular: No New York Heart Association class III or IV heart disease Other: No uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic or immunotherapy No other concurrent biologic or immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior corticosteroids No concurrent systemic glucocorticosteroids Radiotherapy: At least 2 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: No concurrent immunosuppressants
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | United States | 85259-5404 |
2 | Mayo Clinic Jacksonville | Jacksonville | Florida | United States | 32224 |
3 | Illinois Oncology Research Association | Peoria | Illinois | United States | 61602 |
4 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
5 | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | United States | 52403-1206 |
6 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309-1016 |
7 | Siouxland Hematology-Oncology | Sioux City | Iowa | United States | 51101-1733 |
8 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
9 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
10 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
11 | CentraCare Clinic | Saint Cloud | Minnesota | United States | 56303 |
12 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
13 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68131 |
14 | CCOP - Merit Care Hospital | Fargo | North Dakota | United States | 58122 |
15 | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | United States | 43623-3456 |
16 | CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | United States | 17822-2001 |
17 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57709 |
18 | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | United States | 57105-1080 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Svetomir Markovic, MD, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCCTG-N9975
- CDR0000067739