Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma

Completed · Phase 2

Conditions studied: Recurrent Osteosarcoma

In brief

This phase II trial studies how well glembatumumab vedotin works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill them.

Key facts

Study ID: NCT02487979
Run by: National Cancer Institute (NCI)
People needed: 22
Starts: 2016-02-16
Expected to finish: 2021-12-31
Last updated by the study team: 2022-01-18

Who can join

Age: 12 and older, up to 49. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse
Patients must have measurable disease according to RECIST 1.1, and have relapsed or become refractory to conventional therapy
Patient must have archival 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
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)
Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent
Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment
Peripheral absolute neutrophil count (ANC) >= 1000/uL
Platelet count >= 75,000/uL (transfusion independent)
Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
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 1 to < 2 years (male and female: 0.6 mg/dL)
Age 2 to < 6 years (male and female: 0.8 mg/dL)
Age 6 to < 10 years (male and female: 1 mg/dL)
Age 10 to < 13 years (male and female: 1.2 mg/dL)
Age 13 to < 16 years (male: 1.5 mg/dL and female: 1.4 mg/dL)
Age >= 16 (male: 1.7 mg/dL and female: 1.4 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]) < 110 U/L; for the purposes of this study the ULN for SGPT is defined as 45 U/L
Serum albumin > 2 g/dL
Shortening fraction of >= 27% by echocardiogram, or
Ejection fraction of >= 50% by radionuclide angiogram
All patients and/or their parents or legal guardians must sign a written informed consent

You may not qualify if…

Patients with > grade 2 neuropathy according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery
Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E [MMAE]; CDX-011) or other MMAE-containing agents
Patients who have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment
Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition include auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent
Patients with known central nervous system metastasis are not eligible
Patients who have had major surgery within 2 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery
Female patients who are pregnant are ineligible
Lactating females are not eligible unless they have agreed not to breastfeed their infants
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 2 months after the end of study treatment

Where it is running

Banner University Medical Center - Tucson — Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim — Anaheim, California, United States
PCR Oncology — Arroyo Grande, 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
Mattel Children's Hospital UCLA — Los Angeles, California, United States
Valley Children's Hospital — Madera, California, United States
Children's Hospital of Orange County — Orange, California, United States
Lucile Packard Children's Hospital Stanford University — Palo Alto, 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
University of Colorado Hospital — 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
Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut, United States
Yale University — New Haven, Connecticut, United States
Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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