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Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)


Phase 2
N/A
N/A
Not Enrolling
Both
Langerhans Cell Histiocytosis

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Trial Information

Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Conclusion of the study

Safety Issue:

No

Principal Investigator

Tanya Trippett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

94-132

NCT ID:

NCT00588536

Start Date:

January 1995

Completion Date:

June 2009

Related Keywords:

  • Langerhans Cell Histiocytosis
  • Langerhans Cell Histiocytosis
  • LCH
  • 6-Thioguanine
  • 6-TG
  • Methotrexate
  • MTX
  • 94-132
  • Histiocytosis
  • Histiocytosis, Langerhans-Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021