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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
December 26, 2007
January 8, 2008
April 16, 2015
May 4, 2015
May 4, 2015
January 1995
July 2008   (Final data collection date for primary outcome measure)
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 ]
Determine the incidence of complete and partial response and the duration of response in patients wit hLangerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-TG after MTX. [ Time Frame: Conclusion of the study ]
Complete list of historical versions of study NCT00588536 on ClinicalTrials.gov Archive Site
Not Provided
Define the toxicity of this sequential drug combination as defined by NCI Common Toxicity Criteria. [ Time Frame: Conclusion of study ]
Not Provided
Not Provided
 
Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH
Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)
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).
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Langerhans Cell Histiocytosis
  • Drug: Methotrexate
    MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
    Other Name: MTX
  • Drug: 6-Thioguanine
    6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
    Other Name: 6-TG
  • Drug: 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)
Experimental: 1
MTX, 6-TG, Leucovorin
Interventions:
  • Drug: Methotrexate
  • Drug: 6-Thioguanine
  • Drug: Leucovorin Calcium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
June 2009
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00588536
94-132
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Not Provided
Principal Investigator: Tanya Trippett, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP