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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 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: June 21, 2013
Last verified: June 2013
  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: 153Sm-EDTMP
Other: Autologous Peripheral Blood or Bone Marrow 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 Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 153Sm-EDTMP/Stem Cells/Radiotherapy
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, previoulsy harvested autologous peripheral blood or bone marrow stem cells will be infused in order to ameliorate the expected myelosuppression. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
Drug: 153Sm-EDTMP
First, patients will receive a "tracer" infusion of Samarium-153 EDTMP at 1 mCi/kg. We will perform 3D dosimetry using SPECT images after administration of the "tracer" activity 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.
Other Name: Samarium
Other: Autologous Peripheral Blood or Bone Marrow Stem Cell Infusion
Approximately 14 days after administration of "treatment" dose of Samarium, patients will receive previously harvested autologous peripheral blood or bone marrow stem cells to ameliorate the expected myelosuppression.
Radiation: External Beam Radiotherapy
The radiotherapy portion of the combined plan will be delivered according to the judgement of he 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

  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: Margaret Ferreira, MS, RN 410 955 7349 mfogle1@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
  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: June 21, 2013
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, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Samarium ethylenediaminetetramethylenephosphonate
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014