Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma

Inclusion Criteria:

   - Patients must have histologic diagnosis of osteosarcoma at original diagnosis

   - Patients must have had at least one episode of disease recurrence in the lungs without
   limitation on number of episodes of recurrence as long as they meet the following
   criteria:

      - Surgical resection of all possible sites of suspected pulmonary metastases in
      order to achieve a complete remission within 4 weeks prior to study enrollment**

      - Pathologic confirmation of metastases from at least one of the resected sites

         - For patients with bilateral pulmonary metastases, resection must be
         performed from both lungs and the study enrollment must be within 4 weeks
         from date of the last lung surgery

      - Note: If surgery related changes such as atelectasis are seen on the
      post-operative computed tomography (CT) scan, patients will remain eligible to
      enroll as long as the operating surgeon believes that all sites of metastases
      were resected; patients with positive microscopic margins will be eligible to
      enroll

   - 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

   - Patients must have fully recovered from the acute toxic effects of all prior
   chemotherapy, immunotherapy, or radiotherapy prior to entering this study

      - Myelosuppressive anti-cancer therapy: must not have been received within 2 weeks
      of study entry (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 radiation therapy (RT)
      (small port); >= 6 weeks 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

      - Surgery: >= 2 weeks from last major surgery, including pulmonary metastasectomy,
      with the exclusion of a central line placement and core needle or small open
      biopsies

   - Patient must not have received pegfilgrastim within 14 days of enrollment

   - Patient must not have received filgrastim (G-CSF, Neupogen) within 7 days of
   enrollment

   - Patient must not have received immune suppressants: corticosteroids (for other than
   allergic reactions and anaphylaxis), cyclosporine or tacrolimus within 7 days of
   enrollment

      - Note: the use of topical and/or inhalational steroids is allowed

   - Total absolute phagocyte count (APC = [%neutrophils + %monocytes) x white blood cells
   [WBC]) is at least 1000/uL

   - Platelet count >= 50,000/uL

   - 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:

      - 1 month to < 6 months: 0.4 (male) 0.4 (female)

      - 6 months to < 1 year: 0.5 (male), 0.5 (female)

      - 1 to < 2 years: 0.6 (male), 0.6 (female)

      - 2 to < 6 years: 0.8 (male), 0.8 (female)

      - 6 to < 10 years: 1 (male), 1 (female)

      - 10 to < 13 years: 1.2 (male), 1.2 (female)

      - 13 to < 16 years: 1.5 (male), 1.4 (female)

      - >= 16 years: 1.7 (male), 1.4 (female)

   - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

   - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110
   U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)

   - Serum albumin >= 2 g/dL

   - Baseline electrocardiogram (EKG) shows normal corrected QT interval (QTc) interval of
   =< 470 milliseconds (ms)

   - Shortening fraction of >= 27% by echocardiogram, or

   - Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram

   - No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse
   oximetry > 94%

   - Patient has no known history of seizure disorder

   - Central nervous system (CNS) toxicity including peripheral neuropathy =< grade 2

Exclusion Criteria:

   - Patients with distant bone metastases at original diagnosis or relapse (patients with
   only skip lesions will be eligible)

   - Patients with concurrent local and pulmonary recurrence at the time of enrollment;
   note: patients who had local recurrence previously that has been treated and now
   present with an isolated pulmonary recurrence and meet the surgical resection criteria
   stated above will be eligible

   - Patients with primary refractory disease with progression of the primary tumor on
   initial therapy

   - Patients with CNS disease or other sites of extra-pulmonary metastases at the time of
   most recent episode of disease recurrence preceding enrollment

   - Patients with a prior hypersensitivity reaction to sargramostim

   - Patients who have received prior anti-GD2 therapy, including chimeric antigen receptor
   (CAR) T cells directed against GD2 antigen

   - 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; patients should maintain adequate contraception for a minimum of 2
   months after the last dose of ch14.18 (dinutuximab)