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

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ClinicalTrials.gov Identifier: NCT00588536
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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
Enrollment 5
Recruitment Details 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  
Arm/Group Title MTX, 6-TG and Leucovorin
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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)

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title MTX, 6-TG and Leucovorin
Hide Arm/Group Description

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)

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
4
  80.0%
Between 18 and 65 years
1
  20.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Conclusion of the study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MTX, 6-TG and Leucovorin
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Complete Response 2
Stable Disease 1
Progression of Disease 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MTX, 6-TG and Leucovorin
Hide Arm/Group Description

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)

All-Cause Mortality
MTX, 6-TG and Leucovorin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MTX, 6-TG and Leucovorin
Affected / at Risk (%) # Events
Total   2/5 (40.00%)    
General disorders   
Fever  1  1/5 (20.00%)  1
Investigations   
Neutrophil count decreased  1  1/5 (20.00%)  1
Platelet count decreased  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MTX, 6-TG and Leucovorin
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  4/5 (80.00%)  10
Gastrointestinal disorders   
Abdominal pain/cramping  1  1/5 (20.00%)  1
Diarrhea  1  1/5 (20.00%)  1
Nausea  1  1/5 (20.00%)  1
Investigations   
Blood bilirubin increased  1  1/5 (20.00%)  1
Creatinine increased  1  1/5 (20.00%)  1
White blood cell decreased  1  2/5 (40.00%)  4
Neutrophil count decreased  1  1/5 (20.00%)  1
Platelet count decreased  1  2/5 (40.00%)  9
Metabolism and nutrition disorders   
Anorexia  1  1/5 (20.00%)  1
Hypomagnesemia  1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/5 (20.00%)  1
Nervous system disorders   
Headache  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Sore throat  1  1/5 (20.00%)  2
Skin and subcutaneous tissue disorders   
Rash desquamation  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
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
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