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Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma


Phase 2
13 Years
65 Years
Open (Enrolling)
Both
Metastatic Osteosarcoma

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Trial Information

Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma


Inclusion Criteria:



- 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 Criteria:

- Patient may not be pregnant or breastfeeding.

- Patients who have received prior radiotherapy to all areas of current active disease
are not eligible.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess progression free survival of high-risk osteogenic sarcoma to high-dose Samarium-153 EDTMP and external beam radiotherapy

Outcome Description:

6-month progression free survival is the primary endpoint

Outcome Time Frame:

6 months after completion of study

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

J1322

NCT ID:

NCT01886105

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Metastatic Osteosarcoma
  • Osteosarcoma
  • Osteogenic Sarcoma
  • Sarcoma
  • Bone Cancer
  • Osteosarcoma

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410