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Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00010283
  Purpose

RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease.

PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.


Condition Intervention Phase
Breast Cancer
Chronic Myeloproliferative Disorders
Gestational Trophoblastic Tumor
Graft Versus Host Disease
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Neuroblastoma
Ovarian Cancer
Testicular Germ Cell Tumor
Drug: beclomethasone dipropionate
Phase I
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    breast cancer    hemophilia   

MedlinePlus related topics:   Breast Cancer    Cancer    Esophagus Disorders    Kidney Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma    Neuroblastoma    Ovarian Cancer   

ChemIDplus related topics:   Beclomethasone dipropionate    Beclomethasone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
Official Title:   Oral Beclomethasone Dipropionate Capsules for Treatment of Intestinal Graft-Versus-Host Disease: Compassionate Use in Patients With Contraindictions to High-Dose Immunosuppressive Therapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 2000

Detailed Description:

OBJECTIVES: I. Determine the frequency of treatment success in patients with intestinal graft-versus-host disease with contraindications to high-dose immunosuppressive therapy treated with beclomethasone. II. Determine the frequency of adverse events related to the use of this drug in these patients. III. Assess the natural history and outcome of the medical problem for which high-dose immunosuppressive therapy was a contraindication.

OUTLINE: Patients receive oral beclomethasone 4 times daily for 28 days. Treatment may repeat for an additional 28 days as needed. Patients are interviewed weekly to assess treatment success and adverse events. Patients are followed at 1 and 2 weeks.

PROJECTED ACCRUAL: A total of 40-100 patients will be accrued for this study within 3 years.

  Eligibility
Ages Eligible for Study:   5 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven intestinal (esophagus, stomach, small intestine, or colon) graft-versus-host disease (GVHD) exhibiting symptoms such as nausea, vomiting, anorexia, diarrhea, or abdominal pain in the absence of another explanation for these symptoms Specific contraindications to high-dose immunosuppressive therapy, such as: Recurrent malignant disorder for which an allogeneic antitumor effect is desired Aspergillus or other fungal infection Severe myopathy, hyperglycemia, bone problems, or neuropsychiatric symptoms related to corticosteroid use Thrombotic thrombocytopenic purpura or hemolytic uremic syndrome related to immunosuppressive therapy Epstein-Barr virus-related immunoproliferative disease No GVHD unresponsive to prior high-dose immunosuppressive therapy No concurrent infections involving the intestinal tract such as: Salmonella Shigella Clostridium difficile (toxin positive) Rotavirus Giardia lamblia Cytomegalovirus by shell vial culture

PATIENT CHARACTERISTICS: Age: 5 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count adequate Hepatic: Not specified Renal: Not specified Other: Able to swallow oral capsules No persistent vomiting of all oral intake No multiorgan failure No sepsis syndrome, including positive bacterial or fungal cultures within 72 hours of study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior anti-thymocyte globulin Chemotherapy: Concurrent cyclosporine, methotrexate, tacrolimus, mycophenolate mofetil, or prednisone allowed if plan in place to taper or discontinue Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: Not specified Other: At least 7 days since prior investigational agents At least 7 days since prior immunosuppressive agents At least 24 hours since prior drugs that suppress gastric acid secretion (e.g., H2 receptor antagonists or omeprazole) No concurrent drugs that suppress gastric acid secretion

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010283

Locations
United States, Washington
Fred Hutchinson Cancer Research Center    
      Seattle, Washington, United States, 98109

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)

Investigators
Study Chair:     David Hockenbery, MD     Fred Hutchinson Cancer Research Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068475, FHCRC-1500.00, RPCI-DS-99-27, NCI-H01-0067
First Received:   February 2, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00010283
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III breast cancer  
stage IV breast cancer  
stage IIIA breast cancer  
stage IIIB breast cancer  
recurrent childhood acute lymphoblastic leukemia  
recurrent adult Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
Burkitt lymphoma  
extramedullary plasmacytoma  
refractory plasma cell neoplasm  
stage II ovarian epithelial cancer  
stage III ovarian epithelial cancer  
stage IV ovarian epithelial cancer  
recurrent ovarian epithelial cancer  
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
recurrent childhood lymphoblastic lymphoma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
stage III malignant testicular germ cell tumor

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Seminoma
Urogenital Neoplasms
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Preleukemia
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Hemorrhagic thrombocythemia
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Neuroepithelioma
Thrombocythemia, Hemorrhagic
Kidney Diseases
Endocrine Gland Neoplasms
Essential thrombocytosis
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Acute myelogenous leukemia
Genital Neoplasms, Female
Breast Neoplasms
Testicular Neoplasms
Leukemia, Myeloid

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neoplasms by Histologic Type
Disease
Pregnancy Complications, Neoplastic
Immune System Diseases
Blood Protein Disorders
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Syndrome
Cardiovascular Diseases
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on September 05, 2008




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