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A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND# 11042) in Patients With First Pulmonary Recurrence of Osteosarcoma


Phase 2
N/A
39 Years
Not Enrolling
Both
Metastatic Cancer, Sarcoma

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Trial Information

A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND# 11042) in Patients With First Pulmonary Recurrence of Osteosarcoma


OBJECTIVES:

Primary

- Assess the histological findings from patients with first pulmonary recurrence of
osteosarcoma who undergo resection of pulmonary metastases after treatment with 2
courses of aerosolized sargramostim (GM-CSF).

- Determine the event-free survival of patients treated with this drug.

- Determine whether the maximum tolerated dose in the trial of inhaled GM-CSF in adult
patients with melanoma is tolerable in pediatric patients.

Secondary

- Determine the effect of specific thoracic surgical management on outcome in patients
treated with this drug.

OUTLINE: This is a multicenter, dose escalation study. Patients are assigned to 1 of 2
groups according to the extent of pulmonary recurrence (unilateral or bilateral).

- Group I (unilateral recurrence):

- Initial inhalation therapy: Patients receive inhaled sargramostim (GM-CSF) twice
daily on days 1-7. Treatment repeats every other week every 14 days for a total of
2 courses.

- Thoracotomy: Patients undergo thoracotomy on day 22.

- Post-thoracotomy inhalation therapy: Beginning on day 29, or as soon as possible
thereafter, patients resume inhalation therapy as above for up to 12 additional
courses.

- Group II (bilateral recurrence): Patients may be enrolled on study either before or
after the first thoracotomy.

- First thoracotomy: Patients undergo unilateral thoracotomy.

- Initial inhalation therapy: Patients receive inhaled GM-CSF, as soon as possible
after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats
every other week every 14 days for a total of 2 courses.

- Contralateral thoracotomy: Patients undergo contralateral thoracotomy on day 22.

- Post-thoracotomy inhalation therapy: Beginning on day 29, or as soon as possible,
patients resume inhalation therapy as above for up to 12 additional courses.

Treatment in both groups continues in the absence of disease progression or unacceptable
toxicity.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1.6-2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed osteosarcoma at primary diagnosis

- Lesions detected in at least 1 lung that are consistent with metastatic disease
and approachable with thoracotomy

- No prior recurrence of osteosarcoma

- No other sites of metastases

- Resectable pulmonary nodule(s), defined as nodule(s) that are removable without
performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem
bronchus or main pulmonary vessels)

- Prior thoracotomy allowed in patients with imaging consistent with metastatic
involvement in both lungs provided the lung on which the thoracotomy was performed is
disease-free

- No pleural effusion or pleural based nodules

PATIENT CHARACTERISTICS:

Age

- 39 and under

Performance status

- Karnofsky 50-100% (patients over 16 years of age)

- Lansky 50-100% (patients 16 years of age and under)

Life expectancy

- At least 8 weeks

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Pulmonary

- No evidence of dyspnea at rest

- No exercise intolerance

- Pulse oximetry at least 94%

- Baseline FEV_1 at least 80% of predicted

- No history of asthma

- No history of reactive airway disease

- No history of bronchospasm

Other

- Willing and able to perform inhalation therapy

- No medical contraindication to surgical excision

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No other concurrent immunotherapy

- No other concurrent immunomodulating agents

Chemotherapy

- No concurrent anticancer chemotherapy

Endocrine therapy

- No concurrent steroids by any route

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

- No concurrent thoracoscopy or video-assisted thoracic surgery

Other

- No more than 1 prior treatment regimen for osteosarcoma

- No concurrent participation in another COG therapeutic study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Expression of Fas/Fas ligand, presence of dendritic cells, and macrophage infiltration by immunohistochemical analysis before and after the inhalation therapy that follows thoracotomy

Outcome Time Frame:

Up to 6 years

Safety Issue:

No

Principal Investigator

Carola A. S. Arndt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

AOST0221

NCT ID:

NCT00066365

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Sarcoma
  • metastatic osteosarcoma
  • recurrent osteosarcoma
  • lung metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Osteosarcoma
  • Recurrence
  • Sarcoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Newark Beth Israel Medical CenterNewark, New Jersey  07112
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
University of California Davis Cancer CenterSacramento, California  95817
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Children's Medical Center - DaytonDayton, Ohio  45404
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Covenant Children's HospitalLubbock, Texas  79410
Midwest Children's Cancer Center at Children's Hospital of WisconsinMilwaukee, Wisconsin  53226
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Children's Hospital and Research Center OaklandOakland, California  94609
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
Simmons Cooper Cancer InstituteSpringfield, Illinois  62794-9677
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Akron Children's HospitalAkron, Ohio  44308-1062
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Stanford Cancer CenterStanford, California  94305-5824
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Lehigh Valley Hospital - MuhlenbergBethlehem, Pennsylvania  18017
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
Oregon Health and Science University Cancer InstitutePortland, Oregon  97239-3098