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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005610
Other study ID # NCCTG-N9975
Secondary ID CDR0000067739
Status Completed
Phase Phase 2
First received May 2, 2000
Last updated July 12, 2016
Start date September 2000
Est. completion date June 2006

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
sargramostim


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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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