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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin), Metastatic Cancer

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Trial Information

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


OBJECTIVES:

- Determine immunomodulatory effects of aerosolized sargramostim (GM-CSF) in patients
with metastatic melanoma to the lung (part A).

- Determine toxicity profile of this therapy, in terms of pulmonary and hematologic
toxicity, in these patients.

- Determine, preliminarily, the therapeutic effects of this therapy, in terms of
progression-free survival, overall survival, and objective response rate, in these
patients.

- Determine the maximum tolerated dose of GM-CSF in these patients (part B).

OUTLINE: This is a dose-escalation, multicenter study.

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).

- Part A: Cohorts of 5-10 patients receive escalating doses of GM-CSF until the optimal
immunostimulatory dose (ISD) is determined. The optimal ISD is defined as the dose at
which at least 7 of 10 patients experience immunostimulation. Once the optimal ISD is
determined, 10 patients receive aerosolized GM-CSF at a dose halfway between the
optimal ISD and the preceding dose. Dose escalation is discontinued if at least 2 of 5
or at least 4 of 10 patients on a particular dose level experience dose-limiting
toxicity.

- Part B: Cohorts of 3-6 patients receive escalating doses of GM-CSF until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients
are treated at the MTD.

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.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Extent of up-regulation of specific anti-melanoma T cell frequencies (part A)

Safety Issue:

No

Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068654

NCT ID:

NCT00017121

Start Date:

May 2002

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 ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Methodist Medical Center of IllinoisPeoria, Illinois  61636
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
John Stoddard Cancer CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Bismarck Cancer CenterBismarck, North Dakota  58501
Wood County Oncology CenterBowling Green, Ohio  43402
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Flower Hospital Cancer CenterSylvania, Ohio  43560
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Minnesota Oncology Hematology, PA at Maplewood Cancer CenterMaplewood, Minnesota  55109
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Hematology-Oncology Associates of Fredericksburg, IncorporatedFredericksburg, Virginia  22401