Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic Jacksonville
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Illinois
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Peoria, Illinois, Forenede Stater, 61602
- Illinois Oncology Research Association
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Forenede Stater, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Forenede Stater, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Forenede Stater, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58122
- CCOP - Merit Care Hospital
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Ohio
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Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Forenede Stater, 57105-1080
- CCOP - Sioux Community Cancer Consortium
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Progression-free survival
Tidsramme: 2 months
|
2 months
|
|
Median survival
Tidsramme: Up to 1.5 years
|
Up to 1.5 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Quality of life
Tidsramme: Up to 1.5 years
|
Up to 1.5 years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCCTG-N9975
- CDR0000067739 (Registry Identifier: PDQ (Physician Data Query))
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