Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma
High Dose Samarium-153 With Peripheral Blood Stem Cell Support in High Risk Osteogenic Sarcoma
4 other identifiers
interventional
11
1 country
1
Brief Summary
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 25, 2005
CompletedFirst Posted
Study publicly available on registry
October 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
May 1, 2015
CompletedMarch 10, 2020
March 1, 2020
4 years
October 25, 2005
February 3, 2015
March 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor Response
WHO (World Health Organization) tumor measurement criteria used to determine response.
1 week after study treatment
Secondary Outcomes (5)
Predictive Value of Imaging Studies
At Time of Tumor Resection
Overall and Progression-free Survival After Study Treatment
up to 4 years
Toxicity at End of Study Treatment
Continual and at End of Study
Long Term Side Effects of Infusional Samarium-153 After Study Treatment
Continual
Correlative Dose of Radiation by Low Dose and High Dose Samarium-153
completion of treatment
Study Arms (1)
Samarium-153
EXPERIMENTALCytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.
Interventions
Filgrastim will be administered post post chemotherapy until target WBC (white blood cell) count is achieved.
Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered
Sm-EDTMP (low dose) administered after autologous stem cell collection
Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation.
Eligibility Criteria
You may qualify if:
- Diagnosis of osteosarcoma
- High-risk disease, meeting 1 of the following criteria:
- Recurrent disease
- Refractory to conventional therapy
- Newly diagnosed metastatic disease with ≥ 4 pulmonary nodules or multiple bone lesions
- Unresectable primary tumor
- Prior intralesional resection allowed
- Measurable disease by technetium Tc 99m diphosphonate bone scan
- Refractory to all standard therapies or highly unlikely to respond to conventional treatment
- Performance status Karnofsky 60-100%
- Life expectancy more than 8 weeks
- Absolute neutrophil count \> 500/mm\^3
- Platelet count \> 50,000/mm\^3
- Creatinine clearance \> 70 mL/min OR \* Radioisotope glomerular filtration rate normal
- Recovered from prior chemotherapy
You may not qualify if:
- Pregnant or nursing
- Positive pregnancy test for females of childbearing potential
- Fertile patients do not agree to use effective contraception
- Prior radiotherapy to the site of currently active disease
- Concurrent enrollment on protocol JHOC-J0094 allowed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Related Publications (3)
Senthamizhchelvan S, Hobbs RF, Song H, Frey EC, Zhang Z, Armour E, Wahl RL, Loeb DM, Sgouros G. Tumor dosimetry and response for 153Sm-ethylenediamine tetramethylene phosphonic acid therapy of high-risk osteosarcoma. J Nucl Med. 2012 Feb;53(2):215-24. doi: 10.2967/jnumed.111.096677. Epub 2012 Jan 17.
PMID: 22251554RESULTLoeb DM, Hobbs RF, Okoli A, Chen AR, Cho S, Srinivasan S, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Tandem dosing of samarium-153 ethylenediamine tetramethylene phosphoric acid with stem cell support for patients with high-risk osteosarcoma. Cancer. 2010 Dec 1;116(23):5470-8. doi: 10.1002/cncr.25518. Epub 2010 Aug 16.
PMID: 20715156RESULTLoeb DM, Garrett-Mayer E, Hobbs RF, Prideaux AR, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Dose-finding study of 153Sm-EDTMP in patients with poor-prognosis osteosarcoma. Cancer. 2009 Jun 1;115(11):2514-22. doi: 10.1002/cncr.24286.
PMID: 19338063RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David M. Loeb, M.D., Ph.D., Director, Musculoskeletal Tumor Program
- Organization
- Sidney Kimmel Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David M. Loeb, MD, PhD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2005
First Posted
October 27, 2005
Study Start
October 1, 2004
Primary Completion
October 1, 2008
Study Completion
March 1, 2009
Last Updated
March 10, 2020
Results First Posted
May 1, 2015
Record last verified: 2020-03