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Home > "S" Clinical Trials Conditions > Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung  Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
For Condition: Recurrent Melanoma,lung metastases,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: 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.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 7-17 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SvetomirMarkovic, Study Chair, North Central Cancer Treatment Group
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Additional Information:
Study ID Numbers: CDR0000067739; NCCTG-N9975
Study Start Date: September 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005610
Other Lung Metastases Studies:
1. Conventional or Video-Assisted Surgery in Treating Patients With Lung Metastases
2. Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
3. Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer
4. Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
5. Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
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Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
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