Status:
COMPLETED
Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
13-50 years
Phase:
PHASE2
Brief 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 re...
Detailed Description
OBJECTIVES: Primary * Determine the clinical response in patients with recurrent or refractory, metastatic, or unresectable osteosarcoma treated with high-dose samarium Sm 153 lexidronam pentasodium...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00245011
Start Date
October 1 2004
End Date
March 1 2009
Last Update
March 10 2020
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410