Trial Outcomes & Findings for Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH (NCT NCT00588536)
NCT ID: NCT00588536
Last Updated: 2015-05-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Conclusion of the study
Results posted on
2015-05-04
Participant Flow
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
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH
Baseline characteristics by cohort
| Measure |
MTX, 6-TG and Leucovorin
n=5 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Conclusion of the studyOutcome measures
| Measure |
MTX, 6-TG and Leucovorin
n=5 Participants
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)
|
|---|---|
|
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.
Complete Response
|
2 participants
|
|
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.
Stable Disease
|
1 participants
|
|
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.
Progression of Disease
|
2 participants
|
Adverse Events
MTX, 6-TG and Leucovorin
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MTX, 6-TG and Leucovorin
n=5 participants at risk
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)
|
|---|---|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
MTX, 6-TG and Leucovorin
n=5 participants at risk
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)
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
1/5 • Number of events 2
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
4/5 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
1/5 • Number of events 1
|
|
Investigations
White blood cell decreased
|
40.0%
2/5 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Rash desquamation
|
20.0%
1/5 • Number of events 1
|
Additional Information
Dr. Tanya Trippett
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8267
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place