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Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin), Metastatic Cancer

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Trial Information

Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067739

NCT ID:

NCT00005610

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • Metastatic Cancer
  • stage IV melanoma
  • recurrent melanoma
  • lung metastases
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Mayo Clinic JacksonvilleJacksonville, Florida  32224
Illinois Oncology Research AssociationPeoria, Illinois  61602