Langerhans Cell Histiocytosis
Conditions
Keywords
Langerhans Cell Histiocytosis, LCH, 6-Thioguanine, 6-TG, Methotrexate, MTX, 94-132
Brief summary
The objective of this study is to 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-Thioguanine (6-TG) after Methotrexate (MTX).
Interventions
DRUGMethotrexate
MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
DRUG6-Thioguanine
6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
DRUGLeucovorin 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)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with histologic proof of LCH who have multifocal or multisystem disease involvement. * Patients must have a life expectancy of at least 8 weeks. * All patients must have ECOG performance level rating of-\< 2. * Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study, using commercially available drugs. * Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of chemotherapy. * Patients must have adequate liver function (bilirubin \_\< 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine \<\_ 1.5 mg/dl, creatinine clearance \>\_ 60 ml/min/1.73 m2) and normal electrolytes. * Patients should have a granulocyte count \> 500/uL and a platelet count \>\_ 100,000/uL (unless due to disease involvement of the bone marrow). * Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.
Exclusion criteria
* Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Conclusion of the study |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| 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) | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | MTX, 6-TG and Leucovorin |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 2 / 5 |
Outcome results
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MTX, 6-TG and Leucovorin | 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 |
| MTX, 6-TG and Leucovorin | 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 |
| MTX, 6-TG and Leucovorin | 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 |