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

Metastatic Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01886105
• Other study ID #: J1322
• Secondary ID: NA_00075773
• Status: Terminated
• Phase: Phase 2
• Start date: August 19, 2013
• Est. completion date: June 11, 2017

Study information

• Verified date: October 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 11, 2017
• Est. primary completion date: December 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Osteosarcoma
• Osteosarcoma

Intervention

Drug:
• Sm-EDTMP
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.

Other:
• Autologous Stem Cell Infusion
Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.

Radiation:
• External Beam Radiotherapy
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.

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Jazz Pharmaceuticals, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Loeb DM, Hobbs RF, Okoli A, Chen AR, Cho S, Srinivasan S, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Tandem dosing of samarium-153 ethylenediamine tetramethylene phosphoric acid with stem cell support for patients with high-risk osteosarcoma. Cancer. 2010 Dec 1;116(23):5470-8. doi: 10.1002/cncr.25518. Epub 2010 Aug 16. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months post-intervention
Secondary	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.	Up to 48 months