Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Information source: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Osteosarcoma
Intervention: Sm-EDTMP (Drug); Autologous Stem Cell Infusion (Other); External Beam Radiotherapy (Radiation)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sidney Kimmel Comprehensive Cancer Center Official(s) and/or principal investigator(s): David Loeb, MD, PhD, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Susan Markus, RN, BSN, MS, Phone: 410 955 7349, Email: smarkus1@jhmi.edu
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.
Clinical Details
Official title: Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess progression free survival of high-risk osteogenic sarcoma to high-dose Samarium-153 EDTMP and external beam radiotherapy
Secondary outcome: Describe the short and long-term side effects of combined infusional Samarium-153 EDTMP and external beam radiotherapy
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
Minimum age: 13 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Susan Markus, RN, BSN, MS, Phone: 410 955 7349, Email: smarkus1@jhmi.edu
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231, United States; Recruiting David Loeb, MD, PhD, Principal Investigator
Additional Information
Starting date: June 2013
Last updated: February 3, 2015
|