Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

NCT00017121 | Completed Phase 1

• 3 other identifiers: NCCTG-N0071NCI-2012-02385CDR0000068654
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 87

Brief Summary

RATIONALE: Inhaling sargramostim may interfere with the growth of tumor cells and may be an effective treatment for melanoma that has spread to the lung. PURPOSE: This phase I trial is studying the side effects and best dose of inhaled sargramostim in treating patients with melanoma that is metastatic to the lung.

Conditions

Melanoma (Skin); Metastatic Cancer

Keywords

stage IV melanoma; recurrent melanoma; lung metastases

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Up to 6 years

Secondary Outcomes (3)

• Progression-free survival

  Up to 6 years

• Overall survival

  Up to 6 years

• Objective response rate

  Up to 6 years

Study Arms (1)

sargramostim

EXPERIMENTAL

Patients receive aerosolized sargramostim (GM-CSF) twice a day on days 1-7 and 15-21. Treatment repeats every 28 days for 2 courses. Patients with no disease progression after completion of course 2 may continue on treatment until disease progression. Patients are grouped to 1 of 2 dose-escalation regimens (part A vs B). After completion of study therapy, patients are followed at 3 months, every 2 months for 1 year, and then every 3-4 months for 5 years.

Biological: sargramostim

Interventions

sargramostim BIOLOGICAL

sargramostim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma to the lung for which no known standard therapy exists * At least 1 unidimensionally measurable lesion * HLA-A2 positive (part A patients only) * Previously treated CNS metastases allowed provided there is no evidence of disease progression within the past 3 months 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/mm\^3 * Platelet count at least 75,000/mm\^3 * 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 Pulmonary: * No pulmonary disease requiring concurrent active therapy (e.g., supplemental oxygen or bronchodilator) * FEV\_1 at least 65% of predicted and at least 1.5 L Immunologic: * No known immunodeficiency state * No known autoimmune disease * No uncontrolled infection Other: * No active psychotic disorder requiring pharmacotherapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 2 weeks since prior biologic therapy * More than 2 weeks since prior immunotherapy * More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * No other concurrent biologic therapy or immunotherapy * No concurrent G-CSF * No concurrent GM-CSF other than study drug Chemotherapy: * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No concurrent chemotherapy Endocrine therapy: * More than 2 weeks since prior corticosteroids * No concurrent glucocorticosteroids Radiotherapy: * More than 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * More than 7 days since prior parenteral antibiotics * No concurrent parenteral antibiotics * No concurrent immunosuppressive agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (87)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center

Des Moines, Iowa, 50316-2301, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

West Des Moines, Iowa, 50266, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Haematology-Oncology Associates of Ohio and Michigan, PC

Lambertville, Michigan, 48144, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital System

Monroe, Michigan, 48162, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Minnesota Oncology Hematology, PA at Maplewood Cancer Center

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, 58502, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Fremont Memorial Hospital

Fremont, Ohio, 43420, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43617, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, 16801, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Hematology-Oncology Associates of Fredericksburg, Incorporated

Fredericksburg, Virginia, 22401, United States

Location

Related Publications (2)

• Markovic SN, Suman VJ, Nevala WK, Geeraerts L, Creagan ET, Erickson LA, Rowland KM Jr, Morton RF, Horvath WL, Pittelkow MR. A dose-escalation study of aerosolized sargramostim in the treatment of metastatic melanoma: an NCCTG Study. Am J Clin Oncol. 2008 Dec;31(6):573-9. doi: 10.1097/COC.0b013e318173a536.

  PMID: 19060590 RESULT

• Markovic SN, Suman VJ, Schaefer P, et al.: Aerosolized sargramostim for the treatment of metastatic melanoma to the lungs. [Abstract] J Clin Oncol 25 (Suppl 18): A-8565, 488s, 2007.

  RESULT

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Svetomir Markovic, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

US (87)