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Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Cancer; Sarcoma

Intervention: sargramostim (Biological); conventional surgery (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Carola A. Arndt, MD, Study Chair, Affiliation: Mayo Clinic

Summary

RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma that has spread to the lung. PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.

Clinical Details

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

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

Primary outcome:

Status of FAS Ligand in Pre-chemotherapy Sample

Presence of FAS in Pre-chemotherapy Sample

FAS Ligand in Post Chemotherapy Sample

FAS Status in Post Chemotherapy Sample

CD1a Status in Pre Chemotherapy Sample

CD1a Status in Post Chemotherapy Sample

S100 Status in Pre Chemotherapy Sample

S100 Status in Post Chemotherapy Sample

Clusterin Status in Pre Chemotherapy Sample

Clusterin Status in Post Chemotherapy Sample

Event Free Survival (EFS)

Feasibility Success

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: 39 Years. Gender(s): Both.

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 Forced expiratory volume in 1 second (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

Locations and Contacts

Centre Hospitalier Universitaire de Quebec, Quebec G1V 4G2, Canada

San Jorge Children's Hospital, Santurce 00912, Puerto Rico

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama 35294, United States

Phoenix Children's Hospital, Phoenix, Arizona 85016-7710, United States

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona 85724-5024, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Southern California Permanente Medical Group, Downey, California 90242-2814, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California 92354, United States

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California 90801, United States

Children's Hospital and Research Center Oakland, Oakland, California 94609, United States

University of California Davis Cancer Center, Sacramento, California 95817, United States

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States

Stanford Cancer Center, Stanford, California 94305-5824, United States

Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia 20007, United States

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida 33901, United States

University of Florida Shands Cancer Center, Gainesville, Florida 32610-0232, United States

Nemours Children's Clinic, Jacksonville, Florida 32207, United States

Baptist-South Miami Regional Cancer Program, Miami, Florida 33176, United States

Miami Children's Hospital, Miami, Florida 33155, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States

Nemours Children's Clinic - Orlando, Orlando, Florida 32806, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida 32504, United States

All Children's Hospital, St. Petersburg, Florida 33701, United States

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida 33607, United States

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida 33407, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia 30322, United States

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States

Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho 83712-6297, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States

Simmons Cooper Cancer Institute, Springfield, Illinois 62794-9677, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky 40536-0093, United States

Kosair Children's Hospital, Louisville, Kentucky 40232, United States

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland 21215, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Hurley Medical Center, Flint, Michigan 48503, United States

Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan 49503-2560, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan 48910, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216-4505, United States

Children's Mercy Hospital, Kansas City, Missouri 64108, United States

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico 87131-5636, United States

Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales 2145, Australia

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada

Akron Children's Hospital, Akron, Ohio 44308-1062, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

Nationwide Children's Hospital, Columbus, Ohio 43205-2696, United States

Children's Medical Center - Dayton, Dayton, Ohio 45404-1815, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario L8N 3Z5, Canada

Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon 97227, United States

Oregon Health and Science University Cancer Institute, Portland, Oregon 97239-3098, United States

Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania 18107, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-9786, United States

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134-1095, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec H3H 1P3, Canada

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan S7N 4H4, Canada

Palmetto Health South Carolina Cancer Center, Columbia, South Carolina 29203, United States

Greenville Hospital Cancer Center, Greenville, South Carolina 29605, United States

East Tennessee Children's Hospital, Knoxville, Tennessee 37901, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States

M. D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

Covenant Children's Hospital, Lubbock, Texas 79410, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78207, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont 05401, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington 99220-2555, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2004
Last updated: March 17, 2015

Page last updated: August 23, 2015

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