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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

Page last updated: August 23, 2015

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