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Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588536
First received: December 26, 2007
Last updated: June 10, 2009
Last verified: June 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Langerhans Cell Histiocytosis
 Drug: Methotrexate
Drug: 6-Thioguanine
Drug: Leucovorin Calcium
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Define the toxicity of this sequential drug combination as defined by NCI Common Toxicity Criteria. [ Time Frame: Conclusion of study ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: January 1995
Study Completion Date: June 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MTX, 6-TG, Leucovorin
 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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588536

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Tanya Trippett, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tanya Trippett, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588536     History of Changes
Other Study ID Numbers: 94-132
Study First Received: December 26, 2007
Last Updated: June 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Langerhans Cell Histiocytosis
LCH
6-Thioguanine
6-TG
 Methotrexate
MTX
94-132

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Leucovorin
Levoleucovorin
Methotrexate
Thioguanine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
 Pharmacologic Actions
Antidotes
Protective Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on October 17, 2012