Metastatic Cancer Clinical Trial
Official title:
Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung
Verified date | July 2016 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa |
United States | CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | CCOP - Merit Care Hospital | Fargo | North Dakota |
United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Illinois Oncology Research Association | Peoria | Illinois |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | CentraCare Clinic | Saint Cloud | Minnesota |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona |
United States | Siouxland Hematology-Oncology | Sioux City | Iowa |
United States | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota |
United States | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | CCOP - Wichita | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | 2 months | Yes | |
Primary | Median survival | Up to 1.5 years | No | |
Secondary | Quality of life | Up to 1.5 years | No |
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