Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma

Completed · Phase 2

Conditions studied: Metastatic Osteosarcoma, Recurrent Osteosarcoma, Refractory Osteosarcoma, Stage IV Osteosarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7

In brief

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.

Key facts

Study ID: NCT02470091
Run by: Children's Oncology Group
People needed: 56
Starts: 2015-11-21
Expected to finish: 2023-12-31
Last updated by the study team: 2024-01-22

Who can join

Age: 11 and older, up to 49. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Phoenix Childrens Hospital — Phoenix, Arizona, United States
Banner University Medical Center - Tucson — Tucson, Arizona, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim — Anaheim, California, United States
Kaiser Permanente-Bellflower — Bellflower, California, United States
Kaiser Permanente Downey Medical Center — Downey, California, United States
Kaiser Permanente-Fontana — Fontana, California, United States
Loma Linda University Medical Center — Loma Linda, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
Valley Children's Hospital — Madera, California, United States
UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
Children's Hospital of Orange County — Orange, California, United States
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
Kaiser Permanente-San Diego Zion — San Diego, California, United States
Rady Children's Hospital - San Diego — San Diego, California, United States
UCSF Medical Center-Mission Bay — San Francisco, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
Connecticut Children's Medical Center — Hartford, Connecticut, United States
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.