Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00245011
First received: October 25, 2005
Last updated: July 26, 2016
Last verified: July 2016
Results First Received: February 3, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sarcoma
Interventions: Biological: filgrastim
Drug: ifosfamide
Procedure: peripheral blood stem cell transplantation
Radiation: Sm-EDTMP (low dose)
Radiation: sm-EDTMP (higher dose)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Samarium-153/Stem Cell Transplant/Radiation

Samarium Sm153 Lexidronam Pentasodium (Samarium)/Stem Cell Transplant/Radiation arm: receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by collection of stem cells. Samarium is administered after collection of peripheral blood stem cells (PBCT). Once counts recover, while receiving filgrastim daily, a second, higher dose of Samarium-153 is given, followed in 14 days by infusion of the stem cells.

Filgrastim: administered daily until count recovery Ifosfamide: administered as part of Stem Cell transplant preparation. PBCT: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.

Samarium: First dose is administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered after count recover. 14 days after administration of higher dose, patient undergoes autologous stem cell infusion.


Participant Flow:   Overall Study
    Samarium-153/Stem Cell Transplant/Radiation
STARTED   11 
COMPLETED   10 [1] 
NOT COMPLETED   1 
Lack of Efficacy                1 
[1] Subject had disease progression prior to completing study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Samarium-153/Stem Cell Transplant/Radiation

Samarium Sm153 Lexidronam Pentasodium/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell collection. Samarium Sm153 Lexidronam Pentasodium is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of Samarium-153 is given, followed in 14 days by stem cell infusion.

Filgrastim: Filgrastim will be administered every day til count recovery Ifosfamide: Ifosfamide will be administered as part of Stem Cell transplant prep.

Peripheral blood stem cell transplantation: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.

Samarium Sm 153 lexidronam pentasodium: First dose of Sm-EDTMP administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered 7 days later.


Baseline Measures
   Samarium-153/Stem Cell Transplant/Radiation 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
 
<=18 years   6 
Between 18 and 65 years   5 
>=65 years   0 
Age 
[Units: Years]
Median (Full Range)
 18 
 (14 to 30) 
Gender 
[Units: Participants]
 
Female   5 
Male   6 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Tumor Response   [ Time Frame: 1 week after study treatment ]

2.  Secondary:   Predictive Value of Imaging Studies   [ Time Frame: At Time of Tumor Resection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Overall and Progression-free Survival After Study Treatment   [ Time Frame: Continual ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Toxicity at End of Study Treatment   [ Time Frame: Continual and at End of Study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Long Term Side Effects of Infusional Samarium-153 After Study Treatment   [ Time Frame: Continual ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Correlative Dose of Radiation by Low Dose and High Dose Samarium-153   [ Time Frame: completion of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
"Future work will focus on better understanding the factors that contribute to drug delivery and improving efficacy be combination with chemotherapy, biologics, or external beam radiotherapy." (See Publication section of this entry).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David M. Loeb, M.D., Ph.D., Director, Musculoskeletal Tumor Program
Organization: Sidney Kimmel Comprehensive Cancer Center
phone: 410.502.7247
e-mail: loebda@jhmi.edu


Publications of Results:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00245011     History of Changes
Other Study ID Numbers: J0347 CDR0000447134
JHOC-J0347 ( Other Identifier: Johns Hopkins University Clinical Research Office (CRO) )
JHOC-03090802 ( Other Identifier: Johns Hopkins University IRB )
Study First Received: October 25, 2005
Results First Received: February 3, 2015
Last Updated: July 26, 2016
Health Authority: United States: Food and Drug Administration