NCT00064311

Brief Summary

RATIONALE: Antifungals such as ravuconazole may be effective in preventing fungal infections in patients undergoing chemotherapy and stem cell transplantation. PURPOSE: Phase I/II trial to study the effectiveness of ravuconazole in preventing fungal infections in patients undergoing allogeneic stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2003

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

June 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

First QC Date

July 8, 2003

Last Update Submit

March 7, 2012

Conditions

Breast CancerChronic Myeloproliferative DisordersGestational Trophoblastic TumorInfectionLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNeuroblastomaOvarian CancerTesticular Germ Cell Tumor

Keywords

infectionrecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult Burkitt lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV mantle cell lymphomarefractory chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiarelapsing chronic myelogenous leukemiarefractory hairy cell leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage III multiple myelomarecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumordisseminated neuroblastomarecurrent neuroblastomastage II ovarian epithelial cancerrecurrent ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IV breast cancerhigh risk metastatic gestational trophoblastic tumorprimary myelofibrosisrecurrent adult acute lymphoblastic leukemiaadult acute lymphoblastic leukemia in remissionrecurrent adult acute myeloid leukemiaadult acute myeloid leukemia in remissionsecondary acute myeloid leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablestage IIIC breast cancerrecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

ravuconazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Undergoing a non-myeloablative allogeneic hematopoietic stem cell transplantation * Must be able to start prophylactic antifungal therapy within 48 hours of the transplantation chemotherapy preparative regimen and before the initiation of cyclosporine * No diagnosis of deeply invasive fungal infection based on the MSG/EORTC criteria PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 5 times upper limit of normal (ULN) * AST and ALT no greater than 5 times ULN * Alkaline phosphatase no greater than 5 times ULN Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 4 weeks (12 weeks for males) after study participation * Able to swallow oral medication * Sufficient venous access * No prior anaphylaxis attributed to the azole class of antifungals * No concurrent medical condition that may create an unacceptable additional risk for the patient during study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * No concurrent hormonal contraceptives Radiotherapy * Not specified Surgery * Not specified Other * At least 2 weeks since other prior non-FDA approved investigational drugs * No concurrent QTc prolonging medication (e.g., terfenadine, cisapride, quinidine, pimozide, or dofetilide) * No concurrent rifampin * No other concurrent experimental or systemic antifungal therapy * No concurrent agents containing amphotericin B * No other concurrent systemic azole or triazole antifungal agents * No concurrent echinocandins * Concurrent topical antifungals allowed

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

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMyeloproliferative DisordersGestational Trophoblastic DiseaseInfectionsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeuroblastomaOvarian NeoplasmsTesticular Germ Cell TumorLymphoma, T-Cell, CutaneousLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseLeukemia, Hairy CellTesticular NeoplasmsCarcinoma, Ovarian EpithelialPrimary MyelofibrosisLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLymphoma, B-Cell, Marginal ZoneCongenital Abnormalities

Interventions

ER 30346

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 DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersLymphoma, T-CellLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesCarcinomaCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Thomas J. Walsh, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

June 1, 2003

Study Completion

September 1, 2004

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(1)