Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma (Skin); Metastatic Cancer
Intervention: sargramostim (Drug); colony-stimulating factor therapy (Procedure); non-specific immune-modulator therapy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: North Central Cancer Treatment Group Official(s) and/or principal investigator(s):
Svetomir Markovic, MD, PhD, Study Chair, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung
Study design: Treatment
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.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 7-17
months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
Illinois Oncology Research Association, Peoria, Illinois 61602, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, 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 - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States
CentraCare Clinic, Saint Cloud, Minnesota 56303, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States
CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57105-1080, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 2000
Last updated: October 25, 2007
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