NCT00010283

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2000

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

April 13, 2004

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

2 years

First QC Date

February 2, 2001

Last Update Submit

March 31, 2010

Conditions

Breast CancerChronic Myeloproliferative DisordersGestational Trophoblastic TumorGraft Versus Host DiseaseKidney CancerLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesNeuroblastomaOvarian CancerTesticular Germ Cell Tumor

Keywords

stage III breast cancerstage IV breast cancerstage IIIA breast cancerstage IIIB breast cancerrecurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomaBurkitt lymphomaextramedullary plasmacytomarefractory multiple myelomastage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerdisseminated neuroblastomarecurrent neuroblastomarecurrent Wilms tumor and other childhood kidney tumorsstage I multiple myelomastage II multiple myelomastage III multiple myelomarecurrent childhood lymphoblastic lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiastage III malignant testicular germ cell tumorchildhood diffuse large cell lymphomarecurrent malignant testicular germ cell tumorchildhood immunoblastic large cell lymphomachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiachronic idiopathic myelofibrosisessential thrombocythemiatesticular embryonal carcinomatesticular choriocarcinomatesticular teratomatesticular yolk sac tumortesticular embryonal carcinoma and teratomatesticular embryonal carcinoma and teratoma with seminomatesticular embryonal carcinoma and yolk sac tumortesticular embryonal carcinoma and yolk sac tumor with seminomatesticular embryonal carcinoma and seminomatesticular yolk sac tumor and teratomatesticular yolk sac tumor and teratoma with seminomatesticular choriocarcinoma and yolk sac tumortesticular choriocarcinoma and embryonal carcinomatesticular choriocarcinoma and teratomatesticular choriocarcinoma and seminomarefractory hairy cell leukemiarecurrent/refractory childhood Hodgkin lymphomarecurrent ovarian germ cell tumorchronic myelomonocytic leukemiaovarian yolk sac tumorovarian embryonal carcinomaovarian polyembryomaovarian choriocarcinomaovarian immature teratomaovarian mature teratomaovarian monodermal and highly specialized teratomaovarian mixed germ cell tumoracute undifferentiated leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromespoor prognosis metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesgraft versus host diseaseprolymphocytic leukemiaprimary systemic amyloidosisrecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaanaplastic large cell lymphomastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromenoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomachildhood myelodysplastic syndromes

Interventions

beclomethasone dipropionateDRUG

Eligibility Criteria

Age5 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMyeloproliferative DisordersGestational Trophoblastic DiseaseGraft vs Host DiseaseKidney NeoplasmsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesNeuroblastomaOvarian NeoplasmsTesticular Germ Cell TumorPrecursor Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousBurkitt LymphomaCarcinoma, Ovarian EpithelialWilms TumorLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteTesticular NeoplasmsLymphoma, Large B-Cell, DiffuseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPrimary MyelofibrosisThrombocythemia, EssentialTeratoma, TesticularEndodermal Sinus TumorTeratomaSeminomaCarcinoma, EmbryonalLeukemia, Hairy CellRecurrenceLeukemia, Myelomonocytic, ChronicLeukemia, Biphenotypic, AcuteLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, ProlymphocyticImmunoglobulin Light-chain AmyloidosisDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal Zone

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesTrophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypePregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesImmune System DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersLeukemia, LymphoidLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellCarcinomaNeoplasms, Complex and MixedNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidGenital Neoplasms, MaleGenital Diseases, MaleTesticular DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersMesonephromaGerminomaMyelodysplastic-Myeloproliferative DiseasesAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • David Hockenbery, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

April 13, 2004

Study Start

July 1, 2000

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

US(1)