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

Phase 2TerminatedNCT01886105

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Osteosarcoma

Interventions

Sm-EDTMPDRUG

Subjects receive a "tracer" infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post "tracer" infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. "Tracer" activity will be applied to development of the external beam radiation (EBT) planning. Second "treatment" infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg.

Autologous Stem Cell InfusionOTHER

Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.

External Beam RadiotherapyRADIATION

The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning. After the "treatment" infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Percentage of Treated Participants With 6-month Progression Free Survival

Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.

Time frame: 6 months post-intervention

Secondary Outcomes

Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity

Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up.

Time frame: Up to 48 months

Data from ClinicalTrials.gov

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