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

Primary Purpose

Metastatic Osteosarcoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sm-EDTMP
Autologous Stem Cell Infusion
External Beam Radiotherapy
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Osteosarcoma focused on measuring Osteosarcoma, Osteogenic Sarcoma, Sarcoma, Bone Cancer

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SmEDTMP/Autologous Stem Cell Infusion/RT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 4, 2013
Last Updated
October 11, 2019
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI), Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01886105
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Low accrual and loss of funding
Study Start Date
August 19, 2013 (Actual)
Primary Completion Date
December 11, 2015 (Actual)
Study Completion Date
June 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI), Jazz Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Osteosarcoma
Keywords
Osteosarcoma, Osteogenic Sarcoma, Sarcoma, Bone Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SmEDTMP/Autologous Stem Cell Infusion/RT
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sm-EDTMP
Other Intervention Name(s)
Samarium, 153Sm-EDTMP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Autologous Stem Cell Infusion
Other Intervention Name(s)
Stem Cells
Intervention Description
Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiotherapy
Other Intervention Name(s)
Radiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Treated Participants With 6-month Progression Free Survival
Description
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 Outcome Measure Information:
Title
Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Ladle, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma

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