Status:
TERMINATED
Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Jazz Pharmaceuticals
Conditions:
Metastatic Osteosarcoma
Eligibility:
All Genders
10-65 years
Phase:
PHASE2
Brief Summary
The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.
Detailed Description
Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of ext...
Eligibility Criteria
Inclusion
- Patients must be between 13 and 65 years of age, inclusive
- Must have unresectable primary tumor or metastases
- Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not all lesions must be positive on bone scan.
- Creatinine clearance \>70ml/min/1.73m2
- ANC \>500/mm3
- Platelets \>50,000/mm3
- Life expectancy \> 8 weeks
- Karnofsky performance status \>50%
- Stem cell product collected prior to the infusion of Samarium must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry.
Exclusion
- Patient may not be pregnant or breastfeeding.
- Patients who have received prior radiotherapy to all areas of current active disease are not eligible.
Key Trial Info
Start Date :
August 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01886105
Start Date
August 19 2013
End Date
June 11 2017
Last Update
October 29 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231