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

This study is currently recruiting participants.
Verified August 2017 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01886105
First Posted: June 25, 2013
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose
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.

Condition Intervention Phase
Metastatic Osteosarcoma Drug: Sm-EDTMP Other: Autologous Stem Cell Infusion Radiation: External Beam Radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • To assess progression free survival of high-risk osteogenic sarcoma to high-dose Samarium-153 EDTMP and external beam radiotherapy [ Time Frame: 6 months after completion of study ]
    6-month progression free survival is the primary endpoint


Secondary Outcome Measures:
  • Describe the short and long-term side effects of combined infusional Samarium-153 EDTMP and external beam radiotherapy [ Time Frame: Up to 48 months ]
    Short and long-term side effects will be measured by reviewing blood work results and constitutional side effects as voiced by patient participants.


Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SmEDTMP/Autologous Stem Cell Infusion/RT
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.
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 planning. Second "treatment" infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg. After the "treatment" infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the external beam portion of the treatment plan, as necessary. Autologous stem cell infusion is administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.
Other Names:
  • Samarium
  • 153Sm-EDTMP
Other: Autologous Stem Cell Infusion
Approximately 14 days after administration of "treatment" dose of Samarium, patients will receive Autologous Stem Cell Infusion.
Other Name: Stem Cells
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.
Other Name: Radiation

Detailed 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 administration) Auto-Stem cell infusion

DAY 40 (approximately two weeks after stem cell rescue) Initiate external beam radiation therapy upon count recovery

One month following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886105


Contacts
Contact: Brian Ladle, MD, PhD (443) 287-3534 bladle@jhmi.edu
Contact: Tammy Scott, RN 410-614-5990 scottta@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Brian Ladle, MD, PhD         
United States, Texas
Cindy Schwartz Not yet recruiting
Houston, Texas, United States, 77030
Contact: Cindy Schwartz, MD         
Principal Investigator: Cindy Schwartz, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Brian Ladle, MD, PhD Johns Hopkins University
  More Information

Publications:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01886105     History of Changes
Other Study ID Numbers: J1322
NA_00075773 ( Other Identifier: JHMIRB )
First Submitted: June 4, 2013
First Posted: June 25, 2013
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Osteosarcoma
Osteogenic Sarcoma
Sarcoma
Bone Cancer

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Samarium Sm-153 lexidronam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs