A Study of Glembatumumab Vedotin for Treating Patients with Recurrent or Treatment Resistant Osteosarcoma

Overview

About this study

The purpose of this study is to assess 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Must have had histologic verification of osteosarcoma at original diagnosis or relapse
  • Must have measurable disease according to RECIST 1.1, and have relapsed or become refractory to conventional therapy
  • Must have archival tumor specimen available for submission
  • 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
  • Must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
    • Must not have received myelosuppressive chemotherapy within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)
    • At least 7 days since the completion of biologic (anti-neoplastic agent) therapy
    • ≥ 2 weeks since local palliative Radiation therapy (small port)
    • ≥ 6 months must have elapsed if prior craniospinal radiation therapy or if ≥ 50% radiation of pelvis
    • ≥ 6 weeks must have elapsed since other substantial bone marrow radiation
    • Must not have received any monoclonal antibody based therapies within 4 weeks
    • No 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 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
  • Ejection fraction of ≥ 50% by radionuclide angiogram
  • 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

Exclusion Criteria

  • > grade 2 neuropathy according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies, except in cases in which neuropathy is secondary to prior surgery
  • Have previously received CDX-011 (CR011-vc monomethyl auristatin E [MMAE]; CDX-011) or other MMAE-containing agents
  • Have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment
  • 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 
      • Symplostatin 1 as an anti-tumor agent
  • Known central nervous system metastasis
  • Have had major surgery within 2 weeks prior to enrollment 
    • Procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery
  • Female patients who are pregnant
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carola Arndt, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20214349

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