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Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

This study has been completed.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005610
  Purpose

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 Intervention Phase
Melanoma (Skin)
Metastatic Cancer
Drug: sargramostim
Phase II

MedlinePlus related topics:   Cancer    Melanoma   

Drug Information available for:   Sargramostim    Granulocyte-macrophage colony-stimulating factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   September 2000

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005610

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program    
      Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic Jacksonville    
      Jacksonville, Florida, United States, 32224
United States, Illinois
CCOP - Carle Cancer Center    
      Urbana, Illinois, United States, 61801
Illinois Oncology Research Association    
      Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project    
      Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association    
      Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology    
      Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita    
      Wichita, Kansas, United States, 67214-3882
United States, Minnesota
CCOP - Duluth    
      Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota    
      Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic    
      Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium    
      Omaha, Nebraska, United States, 68131
United States, North Dakota
CCOP - Merit Care Hospital    
      Fargo, North Dakota, United States, 58122
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program    
      Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center    
      Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium    
      Sioux Falls, South Dakota, United States, 57105-1080
Rapid City Regional Hospital    
      Rapid City, South Dakota, United States, 57709

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Svetomir Markovic, MD, PhD     Mayo Clinic    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067739, NCCTG-N9975
First Received:   May 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005610
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma  
recurrent melanoma  
lung metastases  

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on December 03, 2008




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