Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Osteosarcoma
Intervention: filgrastim; ifosfamide; peripheral blood stem cell transplantation; Sm-EDTMP (low dose); sm-EDTMP (higher dose)
Intervention description: Filgrastim will be administered post post chemotherapy until target WBC (white blood cell) count is achieved.; Ifosfamide administered IV.; Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered; Sm-EDTMP (low dose) administered after autologous stem cell collection; Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation.
Intervention MeSH terms: Ifosfamide; Samarium Sm-153 lexidronam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 13 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: recurrent osteosarcoma; metastatic osteosarcoma; localized osteosarcoma

Summary:

      RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry
      radiation directly to tumor cells and not harm normal cells. A peripheral stem cell
      transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and
      samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill
      tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem
      cell transplant and radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam
      pentasodium together with autologous stem cell transplant and radiation therapy works in
      treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
    

Eligibility criteria:

        Inclusion

          -  Diagnosis of osteosarcoma

               -  High-risk disease, meeting 1 of the following criteria:

                    -  Recurrent disease

                    -  Refractory to conventional therapy

                    -  Newly diagnosed metastatic disease with ≥ 4 pulmonary nodules or multiple
                       bone lesions

                    -  Unresectable primary tumor

               -  Prior intralesional resection allowed

          -  Measurable disease by technetium Tc 99m diphosphonate bone scan

          -  Refractory to all standard therapies or highly unlikely to respond to conventional
             treatment

          -  Performance status Karnofsky 60-100%

          -  Life expectancy more than 8 weeks

          -  Absolute neutrophil count > 500/mm^3

          -  Platelet count > 50,000/mm^3

          -  Creatinine clearance > 70 mL/min OR * Radioisotope glomerular filtration rate normal

          -  Recovered from prior chemotherapy

        Exclusion

          -  Pregnant or nursing

          -  Positive pregnancy test for females of childbearing potential

          -  Fertile patients do not agree to use effective contraception

          -  Prior radiotherapy to the site of currently active disease

          -  Concurrent enrollment on protocol JHOC-J0094 allowed