Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ifosfamide; Isophosphamide mustard; Lenograstim; Samarium ethylenediaminetetramethylenephosphonate; Samarium Sm-153 lexidronam

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