Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma (NCT00245011) | Clinical Trial Compass
CompletedPhase 2
Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma
United States11 participantsStarted 2004-10
Plain-language 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.
Who can participate
Age range
13 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tumor Response
Timeframe: 1 week after study treatment
Trial details
NCT IDNCT00245011
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins