A Study to Determine the Activity of Robatumumab (SCH 717454) in Participants With Relapsed Osteosarcoma or Ewing's Sarcoma (MK-7454-002/P04720)
Condition: Osteosarcoma; Sarcoma, Ewing's; Peripheral Neuroectodermal Tumor
MeSH terms: Sarcoma; Osteosarcoma; Sarcoma, Ewing; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral
Intervention: robatumumab
Intervention description: Robatumumab IV every two weeks until disease progression.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 219.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: anti-IGF-1R

Summary:

      Participants with relapsed osteosarcoma that can be treated with surgery will be randomized
      to robatumumab administered intravenously (IV) at one of two dose levels. These participants
      will first receive robatumumab, have surgery performed, and continue to receive treatment
      every two weeks until a year of dosing, or until disease progression.

      Participants with unresectable osteosarcoma or Ewing Sarcoma will receive robatumumab IV once
      every two weeks until disease progression. Participants who achieve a complete response (CR)
      or partial response (PR) after tumor evaluations may undergo surgical resection. After
      surgery, participants are eligible to receive 10 mg/kg robatumumab until disease
      recurrence/progression or one year of total dosing, whichever occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A participant must be 11 years of age or older and may be of any race, and gender;
             participants between 4 and 10 years of age, inclusive, may be considered on a
             site-by-site basis.

          -  A participant must have a diagnosis of histologically confirmed osteosarcoma or Ewing
             sarcoma;

          -  A participant with either:

               -  relapsed and resectable osteosarcoma

               -  relapsed and unresectable osteosarcoma that is refractory to standard therapy,
                  ie. has relapsed after prior systemic treatment with active chemotherapy agents

               -  Ewing sarcoma that is refractory to standard systemic therapies

          -  A participant >16 years of age must have an Eastern Cooperative Oncology Group (ECOG)
             performance status of <=2; a participant <=16 years of age must have a Karnofsky
             performance status between 50% and 100% or a Lansky play scale between 50% and 100%

          -  A participant must have adequate organ function.

        Exclusion Criteria:

          -  A participant with a history of another malignancy (with the exception of non-melanoma
             skin cancer or carcinoma in situ of the cervix treated with curative intent at least 2
             years prior to start of treatment, or other adequately treated malignancy for which
             the subject has been disease free for >=5 years)

          -  A participant who has known treated or untreated leptomeningeal metastasis, or a
             metastatic central nervous system lesion

          -  A participant with a history of uncontrolled diabetes mellitus

          -  A participant with a recent myocardial infarction (within the past year); or a
             participant who at the time of Screening presents with unstable or uncontrolled
             angina, New York Heart Association (NYHA) Class III or IV congestive heart failure,
             uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically
             significant electrocardiogram (ECG) abnormality

          -  A participant with an active infection

          -  A participant with clinically significant hepatitis at Screening, or a participant who
             is hepatitis C antibody positive, hepatitis B surface antigen positive, or human
             immunodeficiency virus (HIV) seropositive

          -  A participant who has been treated with an anti-insulin-like growth factor receptor 1
             (anti-IGF-1R)- targeted drug or antibody

          -  A participant with known hypersensitivity to other antibodies, or any accompanying
             excipients associated with these medications.