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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00010283
First received: February 2, 2001
Last updated: March 31, 2010
Last verified: March 2010
  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 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia, Childhood Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia, Childhood Acute Non Lymphoblastic Leukemia AL Amyloidosis Anaplastic Large Cell Lymphoma Anaplastic Plasmacytoma B-cell Lymphomas Burkitt Lymphoma Choriocarcinoma Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloproliferative Disorders Cutaneous T-cell Lymphoma Embryonal Carcinoma Essential Thrombocythemia Follicular Lymphoma Gestational Trophoblastic Tumor Hairy Cell Leukemia Hodgkin Lymphoma Hodgkin Lymphoma, Childhood Homologous Wasting Disease Hydatidiform Mole Kidney Cancer Leukemia, B-cell, Chronic Leukemia, Myeloid Leukemia, T-cell, Chronic Lymphoblastic Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphosarcoma Mantle Cell Lymphoma Multiple Myeloma Mycosis Fungoides Myelodysplastic Syndromes Myelofibrosis Neuroblastoma Neuroepithelioma Ovarian Cancer Ovarian Epithelial Cancer Ovarian Germ Cell Tumor Plasmablastic Lymphoma Polyembryoma Renal Cancer Seminoma Sezary Syndrome Small Non-cleaved Cell Lymphoma Testicular Cancer Wilms' Tumor Yolk Sac Tumor
U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: July 2000
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00010283     History of Changes
Other Study ID Numbers: 1500.00, FHCRC-1500.00, RPCI-DS-99-27, NCI-H01-0067, CDR0000068475
Study First Received: February 2, 2001
Last Updated: March 31, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
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 multiple myeloma
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Renal Cell
Gestational Trophoblastic Disease
Graft vs Host Disease
Kidney Neoplasms
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Plasma Cell
Neuroblastoma
Ovarian Neoplasms
Plasmacytoma
Preleukemia
Syndrome
Testicular Neoplasms
Trophoblastic Neoplasms
Adenocarcinoma
Adnexal Diseases
Blood Protein Disorders
Bone Marrow Diseases
Breast Diseases
Carcinoma
Cardiovascular Diseases
Disease
Endocrine Gland Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 29, 2014