Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH
Information source: Memorial Sloan-Kettering Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Langerhans Cell Histiocytosis
Intervention: Methotrexate (Drug); 6-Thioguanine (Drug); Leucovorin Calcium (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
Tanya Trippett, MD, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center
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).
Clinical Details
Official title: Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: Define the toxicity of this sequential drug combination as defined by NCI Common Toxicity Criteria.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Additional Information
Memorial Sloan-Kettering Cancer Center
Starting date: January 1995
Ending date: December 2008
Last updated: May 19, 2008
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