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Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588536
First Posted: January 8, 2008
Last Update Posted: May 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: April 16, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Langerhans Cell Histiocytosis
Interventions: Drug: Methotrexate
Drug: 6-Thioguanine
Drug: Leucovorin Calcium

  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
Protocol Open to Accrual: 01/10/1995 Protocol Closed to Accrual: 07/25/2006 Primary Completion Date (if applicable): 06/09/2009 Recruitment Location is the medical clinic

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
MTX, 6-TG and Leucovorin

Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs

6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.

Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)


Participant Flow:   Overall Study
    MTX, 6-TG and Leucovorin
STARTED   5 
COMPLETED   5 
NOT COMPLETED   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
MTX, 6-TG and Leucovorin

Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs

6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.

Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)


Baseline Measures
   MTX, 6-TG and Leucovorin 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
 
<=18 years   4 
Between 18 and 65 years   1 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   3 
Male   2 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

1.  Primary:   Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX.   [ Time Frame: Conclusion of the study ]


  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
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  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: Dr. Tanya Trippett
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-8267
e-mail: trippet1@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588536     History of Changes
Other Study ID Numbers: 94-132
First Submitted: December 26, 2007
First Posted: January 8, 2008
Results First Submitted: April 16, 2015
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015