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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00656058 |
RATIONALE: Montelukast may be effective in treating bronchiolitis obliterans after donor stem cell transplant.
PURPOSE: This phase II trial is studying how well montelukast works in treating patients with bronchiolitis obliterans after donor stem cell transplant.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: montelukast sodium Procedure: flow cytometry Procedure: laboratory biomarker analysis Procedure: quality-of-life assessment |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label |
Official Title: | Multi-Institutional Prospective Phase II Study of Montelukast for the Treatment of Bronchiolitis Obliterans Following Allogeneic Stem Cell Transplantation in Children and Adults |
Estimated Enrollment: | 45 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral montelukast sodium once daily for 6 months in the absence of disease progression or unacceptable toxicity.
Blood and urine samples are collected at baseline and at 3 and 6 months to measure leukotriene levels (cysteinyl and LTB4); leukotriene receptor expression on circulating immune cells (including T-cells, B-cells, eosinophils, neutrophils, and monocytes) by flow cytometry; and cytokine levels by immunofluorescent techniques.
Patients complete quality-of-life questionnaires at baseline and at 1, 3, 6, 12, and 24 months.
After completion of study treatment, patients are followed at 1 and 2 years.
Ages Eligible for Study: | 6 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of bronchiolitis obliterans (BO) following allogeneic stem cell transplantation, meeting all of the following criteria:
FEV_1 < 75% of predicted by pulmonary function test (PFT) for height and weight
Meets one of the following criteria:
No active infection
Patients without pathologic evidence of BO must have one other sign of cGVHD present
For diagnosis of cGVHD, a minimum of the following must be present:
Has been on a therapeutic regimen for cGVHD for ≥ 3 months AND has stable or decreasing FEV_1
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, New Jersey | |
Hackensack University Medical Center Cancer Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 |
Principal Investigator: | Ronald E. Gress, MD | NCI - Experimental Transplantation and Immunology Branch |
Study ID Numbers: | CDR0000593080, NCI-08-C-0097, NCI-P07261 |
Study First Received: | April 9, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00656058 |
Health Authority: | Unspecified |
graft versus host disease bronchiolitis obliterans stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma |
stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma |
Juvenile myelomonocytic leukemia Blast Crisis Sezary syndrome Chronic myelogenous leukemia Chronic myelomonocytic leukemia Graft versus host disease Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Ovarian epithelial cancer Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Bronchiolitis Obliterans Mycoses Preleukemia |
Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Acute myeloid leukemia, adult Hodgkin Disease Rhabdomyosarcoma Chronic lymphocytic leukemia Myelodysplastic syndromes Lung Diseases, Interstitial Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, B-cell, chronic Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
Respiratory System Agents Neoplasms Neoplasms by Histologic Type Immune System Diseases Bronchial Diseases Therapeutic Uses |
Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Pharmacologic Actions |