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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01886105
First received: June 4, 2013
Last updated: February 3, 2015
Last verified: February 2015
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 2018
Estimated Primary Completion Date: June 2015 (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

Ages Eligible for Study:   13 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886105

Contacts
Contact: Susan Markus, RN, BSN, MS 410 955 7349 smarkus1@jhmi.edu
Contact: David Loeb, MD, PhD 410 502 7247 loebda@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: David Loeb, MD, PhD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: David Loeb, MD, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01886105     History of Changes
Other Study ID Numbers: J1322, NA_00075773
Study First Received: June 4, 2013
Last Updated: February 3, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Samarium ethylenediaminetetramethylenephosphonate
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 02, 2015