NCT00073944

Brief Summary

RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.

Trial Health

80
On Track

Trial Health Score

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

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

April 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

May 30, 2013

Status Verified

July 1, 2004

Enrollment Period

1.8 years

First QC Date

December 10, 2003

Last Update Submit

May 29, 2013

Conditions

Cancer

Keywords

acute undifferentiated leukemiaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaatypical chronic myeloid leukemia, BCR-ABL1 negativechronic eosinophilic leukemiaprimary myelofibrosischronic myelomonocytic leukemiachronic neutrophilic leukemiaessential thrombocythemiaintraocular lymphomamyelodysplastic/myeloproliferative neoplasm, unclassifiablepolycythemia verapreviously treated myelodysplastic syndromesprimary central nervous system non-Hodgkin lymphomaprolymphocytic leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult T-cell leukemia/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 lymphomarecurrent mycosis fungoides/Sezary syndromerefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesWaldenström macroglobulinemiaadenocarcinoma of the colonadenocarcinoma of the esophagusadenocarcinoma of the pancreasadenocarcinoma of the rectumrecurrent adult brain tumorrecurrent adult primary liver cancerrecurrent colon cancerrecurrent esophageal cancerrecurrent gastric cancerrecurrent melanomarecurrent ovarian epithelial cancerrecurrent pancreatic cancerrecurrent rectal canceradenocarcinoma of the stomachadult anaplastic astrocytomaadult glioblastomaadult pilocytic astrocytomaadult subependymomaadenocarcinoma of the extrahepatic bile ductrecurrent extrahepatic bile duct cancerrecurrent cutaneous T-cell non-Hodgkin lymphomade novo myelodysplastic syndromesrecurrent 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)adult diffuse astrocytomaadult giant cell glioblastomaadult gliosarcomaT-cell large granular lymphocyte leukemia

Interventions

forodesine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Hematologic malignancy that is refractory to at least 1 prior curative treatment * Non-hematologic tumor that is refractory to at least 2 prior therapies, with or without measurable disease, including the following: * Gastrointestinal adenocarcinoma of 1 of the following sites: * Pancreatic * Biliary * Gastric * Colorectal * Esophageal * Melanoma * Ovarian cancer * Astrocytoma brain tumor * Not immediately eligible for any other treatment that would be potentially curative or life-prolonging, in the opinion of the investigator * Patients who may be candidates for future bone marrow transplantation are eligible * No brain metastases (other than astrocytomas) * No clinically significant pleural effusion * No complete tumor obstruction (e.g., bronchus, ureter, or bowel) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * WBC at least 3,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count greater than 50,000/mm\^3 * Hematocrit stable without the need for transfusion (epoetin alfa support allowed) Hepatic * Bilirubin less than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome) * SGOT and SGPT less than 2 times ULN * No active hepatitis B or C Renal * Creatinine clearance at least 50 mL/min Cardiovascular * No American Heart Association class III or IV cardiac disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active systemic infection requiring IV antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Concurrent corticosteroids allowed provided the patient is on a stable regimen Radiotherapy * Not specified Surgery * Not specified Other * Recovered from prior therapy * No grade 2-4 toxicity * More than 3 weeks since prior antineoplastic and/or investigational therapy * No other concurrent systemic antineoplastic or investigational therapy

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

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

NeoplasmsLeukemia, Biphenotypic, AcuteLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativePdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicThrombocythemia, EssentialIntraocular LymphomaMyeloproliferative DisordersPolycythemia VeraLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaWaldenstrom MacroglobulinemiaColonic NeoplasmsAdenocarcinoma Of EsophagusRectal NeoplasmsBrain NeoplasmsCarcinoma, HepatocellularEsophageal NeoplasmsStomach NeoplasmsMelanomaCarcinoma, Ovarian EpithelialPancreatic NeoplasmsAstrocytomaGlioblastomaGlioma, SubependymalBile Duct NeoplasmsLymphoma, T-Cell, CutaneousLymphoma, B-Cell, Marginal ZoneCongenital AbnormalitiesGliosarcomaLeukemia, Large Granular Lymphocytic

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphomaLymphadenopathyLeukemia, MyeloidMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic DisordersEye NeoplasmsNeoplasms by SiteBone Marrow NeoplasmsHematologic NeoplasmsLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsLiver DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGliomaNeoplasms, NeuroepithelialEpendymomaBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, T-Cell

Study Officials

  • Alex Shalaurov, MD, PhD

    Inveresk Research Group, Incorporated

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 10, 2003

First Posted

December 11, 2003

Study Start

April 1, 2003

Primary Completion

January 1, 2005

Last Updated

May 30, 2013

Record last verified: 2004-07

Locations

US(1)