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

Phase 2

Completed

• Conditions: Metastatic Cancer; Melanoma (Skin)
• Interventions: Biological: sargramostim

• Registration Number: NCT00005610
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

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.

Study Timeline

• Study First Submitted: 2000-05-02
• Study Start: 2000-09
• Study First Submitted QC: 2004-02-11
• Study First Posted: 2004-02-12
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sargramostim	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.

Primary Outcome Measures

Name	Time	Method
Median survival	Up to 1.5 years
Progression-free survival	2 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	Up to 1.5 years

Trial Locations

Locations (18)

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Duluth; 🇺🇸 Duluth, Minnesota, United States

CentraCare Clinic; 🇺🇸 Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota; 🇺🇸 Saint Louis Park, Minnesota, United States

CCOP - Geisinger Clinic and Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium; 🇺🇸 Omaha, Nebraska, United States

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Siouxland Hematology-Oncology; 🇺🇸 Sioux City, Iowa, United States

Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Merit Care Hospital; 🇺🇸 Fargo, North Dakota, United States

CCOP - Toledo Community Hospital Oncology Program; 🇺🇸 Toledo, Ohio, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium; 🇺🇸 Sioux Falls, South Dakota, United States