High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00634322
First received: March 6, 2008
Last updated: September 9, 2014
Last verified: September 2014
Results First Received: November 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Osteosarcoma
Interventions: Drug: glucarpidase
Drug: leucovorin

  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
High-dose Methotrexate Plus Glucarpidase Then Placebo First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
High-dose Methotrexate Plus Placebo Then Glucarpidase First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
Arm C, Compassionate Use of Glucarpidase Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg

Participant Flow:   Overall Study
    High-dose Methotrexate Plus Glucarpidase Then Placebo     High-dose Methotrexate Plus Placebo Then Glucarpidase     Arm C, Compassionate Use of Glucarpidase  
STARTED     1     1     5  
COMPLETED     1     1     5  
NOT COMPLETED     0     0     0  



  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
High-dose Methotrexate Plus Glucarpidase Then Placebo First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
High-dose Methotrexate Plus Placebo Then Glucarpidase First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
Arm C, Compassionate Use of Glucarpidase Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
Total Total of all reporting groups

Baseline Measures
    High-dose Methotrexate Plus Glucarpidase Then Placebo     High-dose Methotrexate Plus Placebo Then Glucarpidase     Arm C, Compassionate Use of Glucarpidase     Total  
Number of Participants  
[units: participants]
  1     1     5     7  
Age  
[units: participants]
       
<=18 years     1     1     3     5  
Between 18 and 65 years     0     0     2     2  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     1     1     3     5  
Male     0     0     2     2  



  Outcome Measures

1.  Primary:   Patients Progressing to Next Chemotherapy Cycle   [ Time Frame: 1 week after intervention ]


  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
No efficacy endpoints were reported due to early termination (insufficient enrollment).


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: VP Clinical Development, BTG International
Organization: BTG International (Protherics)
phone: 610-943-3632
e-mail: janet.rush@btgplc.com


No publications provided


Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00634322     History of Changes
Other Study ID Numbers: PR001-CLN-pro012, MDACC #2006-0246
Study First Received: March 6, 2008
Results First Received: November 30, 2012
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration