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

NCT01886105 | Terminated Phase 2 Results DMC

• 2 other identifiers: J1322NA_00075773
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Osteosarcoma

Keywords

Osteosarcoma; Osteogenic Sarcoma; Sarcoma; Bone Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Up to 48 months

Study Arms (1)

SmEDTMP/Autologous Stem Cell Infusion/RT

EXPERIMENTAL

DAY 1 Tracer dose 153Sm-EDTMP administration (1 mCi/kg) SPECT/High-resolution CT at 4 hours. SPECT/CT (low resolution) at 24 and 48 hrs DAY 7 Individualized treatment dose 153Sm-EDTMP administration (max 30 mCi/kg) SPECT scans at 4, 24 and 48 hours DAY 21 (2 weeks following treatment dose) Auto-Stem cell infusion DAY 40 (approx. two weeks after stem cell rescue) Initiate EBT upon count recovery 1 MONTH following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET

Drug: Sm-EDTMP; Other: Autologous Stem Cell Infusion; Radiation: External Beam Radiotherapy

Interventions

Sm-EDTMP DRUG

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.

Also known as: Samarium, 153Sm-EDTMP

SmEDTMP/Autologous Stem Cell Infusion/RT

Autologous Stem Cell Infusion OTHER

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

Also known as: Stem Cells

SmEDTMP/Autologous Stem Cell Infusion/RT

External Beam Radiotherapy RADIATION

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.

Also known as: Radiation

SmEDTMP/Autologous Stem Cell Infusion/RT

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient may not be pregnant or breastfeeding.
• Patients who have received prior radiotherapy to all areas of current active disease are not eligible.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Osteosarcoma; Sarcoma; Bone Neoplasms

Interventions

samarium Sm-153 lexidronam; Samarium; Radiation

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Physical Phenomena

Limitations and Caveats

The study had low enrollment - 4 patients. Those that did enroll had very late stage disease and the therapy provided on this trial was the last therapy given for all 4 patients. Of the patients that began therapy, only 1 completed planned therapy.

Results Point of Contact

• Title: Dr. Brian H. Ladle
• Organization: Johns Hopkins University

bladle@jhmi.edu

443-287-3534

Study Officials

• Brian Ladle, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 25, 2013
• Study Start: August 19, 2013
• Primary Completion: December 11, 2015
• Study Completion: June 11, 2017
• Last Updated: October 29, 2019
• Results First Posted: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)