search
Back to results

Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma

Primary Purpose

Metastatic Osteosarcoma, Recurrent Osteosarcoma, Refractory Osteosarcoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Denosumab
Laboratory Biomarker Analysis
Pharmacological Study
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Osteosarcoma

Eligibility Criteria

11 Years - 49 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients must have a bone age of equal to or greater than 12 years of age as determined by local read of appropriate radiographic imaging
  • Male patients must have a bone age of equal to or greater than 14 years of age as determined by local read of appropriate radiographic imaging
  • Patients must have relapsed or become refractory to conventional therapy, with a regimen including some combination of high dose methotrexate, doxorubicin, cisplatin, ifosfamide and etoposide; and have had histologic verification of osteosarcoma at original diagnosis or at the time of recurrence
  • Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  • Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment

    • Patients will only be eligible after they have undergone complete surgical resection of suspected metastatic disease that is histopathologically confirmed to be osteosarcoma prior to enrollment

      • Note: the definition of complete resections is: gross resection of all disease as per the operating surgeon; post-operative imaging is not required for confirmation of complete resection

    • Patients must undergo resection of any lung lesion meeting criteria for likely metastatic disease, defined as:

      • 3 or more lesions > 5 mm in diameter OR a single lesion > 1 cm

    • Patients with lung as the only site of resected metastatic disease must have refused participation in protocol AOST1421

      • Note: This applies if AOST1421 is open to enrollment at the enrolling institution on the day the patient consents
  • Patient must have adequate tumor specimen available for submission
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

    • Age: 11 to < 13 years old; 1.2 (male, female) maximum serum creatinine (mg/dL)
    • Age: 13 to < 16 years old; 1.5 (male), 1.4 (female) maximum serum creatinine (mg/dL)
    • Age: >= 16 years old; 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN for age
  • Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)

Exclusion Criteria:

  • Patients with known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
  • Patients who are receiving other cancer directed therapy at the time of enrollment
  • Patients who have previously received denosumab
  • Patients who have previously received mithramycin, strontium-89, samarium-153 or rhenium
  • Patients receiving bisphosphonates

  • Pre-existing conditions

    • Disorders associated with abnormal bone metabolism
    • Hypocalcemia that is not corrected with oral calcium supplementation
    • Vitamin D < 20 mg/mL
    • Paget's disease
    • Prior history or current evidence of osteonecrosis of the jaw
    • Any dental or oral condition likely to result in disruption of mucosal integrity during denosumab therapy including: active dental or jaw condition requiring oral surgery or tooth extraction; non-healed dental or oral surgery or planned invasive dental procedures during the anticipated course of study therapy
    • Unstable systemic disease, excluding osteosarcoma, such as unstable proximal renal tubule dysfunction (Fanconi syndrome) or congestive heart failure

  • Pregnancy and breast feeding

    • Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants while on study therapy and through 5 months after completion of study therapy
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 5 months after the end of study treatment
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Sites / Locations

  • Children's Hospital of Alabama
  • Phoenix Childrens Hospital
  • Banner University Medical Center - Tucson
  • Arkansas Children's Hospital
  • Kaiser Permanente-Anaheim
  • Kaiser Permanente-Bellflower
  • Kaiser Permanente Downey Medical Center
  • Kaiser Permanente-Fontana
  • Loma Linda University Medical Center
  • Children's Hospital Los Angeles
  • Kaiser Permanente Los Angeles Medical Center
  • Valley Children's Hospital
  • Children's Hospital and Research Center at Oakland
  • Children's Hospital of Orange County
  • University of California Davis Comprehensive Cancer Center
  • Kaiser Permanente-San Diego Zion
  • Rady Children's Hospital - San Diego
  • UCSF Medical Center-Mission Bay
  • Children's Hospital Colorado
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
  • Connecticut Children's Medical Center
  • Alfred I duPont Hospital for Children
  • Children's National Medical Center
  • University of Florida Health Science Center - Gainesville
  • Nemours Children's Clinic-Jacksonville
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Nicklaus Children's Hospital
  • AdventHealth Orlando
  • Nemours Children's Hospital
  • Johns Hopkins All Children's Hospital
  • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Saint Mary's Hospital
  • Children's Healthcare of Atlanta - Egleston
  • Kapiolani Medical Center for Women and Children
  • Saint Luke's Mountain States Tumor Institute
  • Centralia Oncology Clinic
  • Lurie Children's Hospital-Chicago
  • University of Illinois
  • University of Chicago Comprehensive Cancer Center
  • Carle on Vermilion
  • Cancer Care Specialists of Illinois - Decatur
  • Carle Physician Group-Effingham
  • Crossroads Cancer Center
  • Carle Physician Group-Mattoon/Charleston
  • Cancer Care Center of O'Fallon
  • Saint Jude Midwest Affiliate
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Riley Hospital for Children
  • Saint Vincent Hospital and Health Care Center
  • University of Iowa/Holden Comprehensive Cancer Center
  • University of Kentucky/Markey Cancer Center
  • Norton Children's Hospital
  • Ochsner Medical Center Jefferson
  • Maine Children's Cancer Program
  • Sinai Hospital of Baltimore
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Walter Reed National Military Medical Center
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • UMass Memorial Medical Center - University Campus
  • C S Mott Children's Hospital
  • Wayne State University/Karmanos Cancer Institute
  • Ascension Saint John Hospital
  • Helen DeVos Children's Hospital at Spectrum Health
  • Bronson Methodist Hospital
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
  • University of Minnesota/Masonic Cancer Center
  • Mayo Clinic in Rochester
  • University of Mississippi Medical Center
  • Children's Mercy Hospitals and Clinics
  • Washington University School of Medicine
  • Mercy Hospital Saint Louis
  • Children's Hospital and Medical Center of Omaha
  • University of Nebraska Medical Center
  • Sunrise Hospital and Medical Center
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  • Dartmouth Hitchcock Medical Center
  • Hackensack University Medical Center
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
  • Rutgers Cancer Institute of New Jersey
  • Newark Beth Israel Medical Center
  • University of New Mexico Cancer Center
  • Albany Medical Center
  • Roswell Park Cancer Institute
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester
  • State University of New York Upstate Medical University
  • UNC Lineberger Comprehensive Cancer Center
  • Carolinas Medical Center/Levine Cancer Institute
  • Wake Forest University Health Sciences
  • Sanford Broadway Medical Center
  • Children's Hospital Medical Center of Akron
  • UHHS-Chagrin Highlands Medical Center
  • Cincinnati Children's Hospital Medical Center
  • Case Western Reserve University
  • Rainbow Babies and Childrens Hospital
  • Cleveland Clinic Foundation
  • Nationwide Children's Hospital
  • Dayton Children's Hospital
  • University of Oklahoma Health Sciences Center
  • Oregon Health and Science University
  • Penn State Children's Hospital
  • Children's Hospital of Philadelphia
  • Children's Oncology Group
  • Saint Christopher's Hospital for Children
  • Children's Hospital of Pittsburgh of UPMC
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Prisma Health Richland Hospital
  • Sanford USD Medical Center - Sioux Falls
  • Saint Jude Children's Research Hospital
  • Vanderbilt University/Ingram Cancer Center
  • Dell Children's Medical Center of Central Texas
  • Driscoll Children's Hospital
  • Medical City Dallas Hospital
  • UT Southwestern/Simmons Cancer Center-Dallas
  • Cook Children's Medical Center
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  • Children's Hospital of San Antonio
  • University of Texas Health Science Center at San Antonio
  • Primary Children's Hospital
  • University of Vermont and State Agricultural College
  • University of Virginia Cancer Center
  • Children's Hospital of The King's Daughters
  • Virginia Commonwealth University/Massey Cancer Center
  • Seattle Children's Hospital
  • Providence Sacred Heart Medical Center and Children's Hospital
  • West Virginia University Healthcare
  • Children's Hospital of Wisconsin
  • University of Alberta Hospital
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Children's Hospital
  • Hospital for Sick Children
  • The Montreal Children's Hospital of the MUHC
  • Centre Hospitalier Universitaire de Quebec
  • San Jorge Children's Hospital
  • University Pediatric Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (denosumab)

Arm Description

Patients receive denosumab SC on day 1 (days 1, 8, and 15 of course 1 only). Treatment repeats every 4 weeks (28 days) for up to 24 months or 26 courses, whichever occurs first, in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Disease Control Rate (Cohort I)
Disease control interval was calculated as the time from enrolment until detection of new disease or progression of an existing site of disease as determined by the treating physician. Disease control interval of at least 4 months was considered disease control success.
Response Evaluation Criteria in Solid Tumors (RECIST) Response (Complete Response [CR] or Partial Response [PR] vs Not CR or PR) (Cohort I)
Per Response Evaluation Criteria In Solid TumorsCriteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Disease Control Rate (Cohort II)
Disease control interval was calculated as the time from enrolment until detection of new disease as determined by the treating physician. Disease control interval of at least 12 months was considered disease control success.

Secondary Outcome Measures

Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Sample means of trough concentrations of denosumab will be calculated.
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Sample medians of trough concentrations of denosumab will be calculated.
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide in pg/ml
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio expressed as nMol BCE/mmol creatinine
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
The number of cycles where a dose-limiting toxicity was identified where dose-limiting toxicity is defined in the protocol using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Response Rate (CR or PR) for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I)
Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances.
Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I)
Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances.
Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort II)
Disease control interval was calculated at the time from enrolment until detection of new disease as determined by the treating physician. The proportion of patients who experience disease control of at least 12 months will be estimated by the method of Kaplan and Meier.

Full Information

First Posted
April 14, 2015
Last Updated
December 29, 2022
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02470091
Brief Title
Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma
Official Title
Phase 2 Study of Denosumab (NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2015 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as denosumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether denosumab therapy either increases the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to historical Children's Oncology Group (COG) experience or denosumab therapy produces an objective response rate greater than 5% (Cohort 1). II. To determine whether denosumab therapy increases the disease control rate at 12 months in patients with recurrent resected osteosarcoma as compared to historical COG experience (Cohort 2). SECONDARY OBJECTIVES: I. To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab in subjects with recurrent osteosarcoma. II. To describe the tolerability of denosumab in subjects with recurrent osteosarcoma. III. To report the disease control rate and objective response rate for patients with recurrent osteosarcoma limited to bone. IV. To investigate biological markers potentially associated with response to denosumab in patients with recurrent osteosarcoma. OUTLINE: Patients receive denosumab subcutaneously (SC) on day 1 (days 1, 8, and 15 of course 1 only). Treatment repeats every 4 weeks (28 days) for up to 24 months or 26 courses, whichever occurs first, in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Osteosarcoma, Recurrent Osteosarcoma, Refractory Osteosarcoma, Stage IV Osteosarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (denosumab)
Arm Type
Experimental
Arm Description
Patients receive denosumab SC on day 1 (days 1, 8, and 15 of course 1 only). Treatment repeats every 4 weeks (28 days) for up to 24 months or 26 courses, whichever occurs first, in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
Denosumab
Other Intervention Name(s)
AMG 162, AMG-162, Denosumab Biosimilar TK-006, Prolia, TK-006, Xgeva
Intervention Description
Given SC
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Disease Control Rate (Cohort I)
Description
Disease control interval was calculated as the time from enrolment until detection of new disease or progression of an existing site of disease as determined by the treating physician. Disease control interval of at least 4 months was considered disease control success.
Time Frame
At 4 months
Title
Response Evaluation Criteria in Solid Tumors (RECIST) Response (Complete Response [CR] or Partial Response [PR] vs Not CR or PR) (Cohort I)
Description
Per Response Evaluation Criteria In Solid TumorsCriteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
At 4 months
Title
Disease Control Rate (Cohort II)
Description
Disease control interval was calculated as the time from enrolment until detection of new disease as determined by the treating physician. Disease control interval of at least 12 months was considered disease control success.
Time Frame
At 12 months
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Description
Sample means of trough concentrations of denosumab will be calculated.
Time Frame
Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6
Title
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Description
Sample medians of trough concentrations of denosumab will be calculated.
Time Frame
Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6
Title
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Description
Serum c-telopeptide in pg/ml
Time Frame
Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7
Title
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Description
Urine n-telopeptide to creatinine ratio expressed as nMol BCE/mmol creatinine
Time Frame
Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7
Title
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Description
The number of cycles where a dose-limiting toxicity was identified where dose-limiting toxicity is defined in the protocol using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time Frame
Minimum of 2 years
Title
Response Rate (CR or PR) for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I)
Description
Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances.
Time Frame
Up to 3 years post-treatment
Title
Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I)
Description
Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances.
Time Frame
At 4 months
Title
Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort II)
Description
Disease control interval was calculated at the time from enrolment until detection of new disease as determined by the treating physician. The proportion of patients who experience disease control of at least 12 months will be estimated by the method of Kaplan and Meier.
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients must have a bone age of equal to or greater than 12 years of age as determined by local read of appropriate radiographic imaging Male patients must have a bone age of equal to or greater than 14 years of age as determined by local read of appropriate radiographic imaging Patients must have relapsed or become refractory to conventional therapy, with a regimen including some combination of high dose methotrexate, doxorubicin, cisplatin, ifosfamide and etoposide; and have had histologic verification of osteosarcoma at original diagnosis or at the time of recurrence Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment Patients will only be eligible after they have undergone complete surgical resection of suspected metastatic disease that is histopathologically confirmed to be osteosarcoma prior to enrollment Note: the definition of complete resections is: gross resection of all disease as per the operating surgeon; post-operative imaging is not required for confirmation of complete resection Patients must undergo resection of any lung lesion meeting criteria for likely metastatic disease, defined as: 3 or more lesions > 5 mm in diameter OR a single lesion > 1 cm Patients with lung as the only site of resected metastatic disease must have refused participation in protocol AOST1421 Note: This applies if AOST1421 is open to enrollment at the enrolling institution on the day the patient consents Patient must have adequate tumor specimen available for submission Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: Age: 11 to < 13 years old; 1.2 (male, female) maximum serum creatinine (mg/dL) Age: 13 to < 16 years old; 1.5 (male), 1.4 (female) maximum serum creatinine (mg/dL) Age: >= 16 years old; 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN for age Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL) Exclusion Criteria: Patients with known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D) Patients who are receiving other cancer directed therapy at the time of enrollment Patients who have previously received denosumab Patients who have previously received mithramycin, strontium-89, samarium-153 or rhenium Patients receiving bisphosphonates Pre-existing conditions Disorders associated with abnormal bone metabolism Hypocalcemia that is not corrected with oral calcium supplementation Vitamin D < 20 mg/mL Paget's disease Prior history or current evidence of osteonecrosis of the jaw Any dental or oral condition likely to result in disruption of mucosal integrity during denosumab therapy including: active dental or jaw condition requiring oral surgery or tooth extraction; non-healed dental or oral surgery or planned invasive dental procedures during the anticipated course of study therapy Unstable systemic disease, excluding osteosarcoma, such as unstable proximal renal tubule dysfunction (Fanconi syndrome) or congestive heart failure Pregnancy and breast feeding Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants while on study therapy and through 5 months after completion of study therapy Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 5 months after the end of study treatment All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine A Janeway
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
Kaiser Permanente-Anaheim
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
Kaiser Permanente-Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Kaiser Permanente Downey Medical Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Kaiser Permanente-Fontana
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente-San Diego Zion
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Medical Center-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Alfred I duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nemours Children's Clinic-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Saint Joseph's Hospital/Children's Hospital-Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Saint Mary's Hospital
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Lurie Children's Hospital-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Carle on Vermilion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Cancer Care Center of O'Fallon
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Saint Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
C S Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Helen DeVos Children's Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Children's Hospital and Medical Center of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
UHHS-Chagrin Highlands Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Rainbow Babies and Childrens Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Saint Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Prisma Health Richland Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
University of Vermont and State Agricultural College
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
West Virginia University Healthcare
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Children's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
The Montreal Children's Hospital of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
San Jorge Children's Hospital
City
San Juan
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
University Pediatric Hospital
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma

We'll reach out to this number within 24 hrs