Clinical trial NCT01886105: Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Official title: Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Osteosarcoma
Keywords: Osteosarcoma
Osteogenic Sarcoma
Sarcoma
Bone Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Jazz Pharmaceuticals
First posted: 2013-06-25
Enrollment: 4
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Treated Participants With 6-month Progression Free Survival
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Brian Ladle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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