NCT00042900

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_1

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, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 8, 2003

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

August 5, 2002

Last Update Submit

June 4, 2013

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous ConditionSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

AIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaT-cell large granular lymphocyte leukemiaWaldenström macroglobulinemiaaccelerated phase chronic myelogenous leukemiaacute undifferentiated leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionprimary myelofibrosisanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomablastic phase chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesessential thrombocythemiaextramedullary plasmacytomaintraocular lymphomaisolated plasmacytoma of bonemeningeal chronic myelogenous leukemiamonoclonal gammopathy of undetermined significancepolycythemia verapreviously treated myelodysplastic syndromesprimary central nervous system non-Hodgkin lymphomaprimary systemic amyloidosisprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiarecurrent adult Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin 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 syndromessmall intestine lymphomastage III adult Hodgkin lymphomastage III adult T-cell leukemia/lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Burkitt lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III chronic lymphocytic leukemiastage III cutaneous T-cell non-Hodgkin lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III multiple myelomastage III mycosis fungoides/Sezary syndromestage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV chronic lymphocytic leukemiastage IV cutaneous T-cell non-Hodgkin lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV mycosis fungoides/Sezary syndromeuntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiauntreated hairy cell leukemiastage IV adult Hodgkin lymphomastage IV adult T-cell leukemia/lymphomaunspecified adult solid tumor, protocol specificrecurrent 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 lymphoma

Interventions

pyroxamideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor or hematologic malignancy * Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no curative or life- prolonging therapy is available * Measurable or clinically evaluable disease * Elevated tumor marker is acceptable for evaluable disease * No known carcinomatous meningitis, primary brain tumors, or metastatic brain disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 125,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin normal * AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) * PT no greater than 1.5 times ULN Renal * Creatinine normal Other * HIV-positive status allowed * Prior malignancy allowed * No severe physical or emotional illness that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent bone marrow growth factors Chemotherapy * See Disease Characteristics * At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics * At least 4 weeks since prior wide-field radiotherapy and recovered * At least 2 weeks since prior limited-field radiotherapy and recovered * Recovered from prior radiotherapy Surgery * See Disease Characteristics Other * No other concurrent antitumor treatment

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesPrecancerous ConditionsLeukemia, Large Granular LymphocyticWaldenstrom MacroglobulinemiaLeukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcutePrimary MyelofibrosisLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseThrombocythemia, EssentialIntraocular LymphomaMonoclonal Gammopathy of Undetermined SignificancePolycythemia VeraImmunoglobulin Light-chain AmyloidosisLeukemia, ProlymphocyticHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLymphoma, B-Cell, Marginal Zone

Interventions

pyroxamide

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, T-CellLeukemia, LymphoidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-CellLymphadenopathyCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyelodysplastic-Myeloproliferative DiseasesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersEye NeoplasmsNeoplasms by SiteHypergammaglobulinemiaBone Marrow NeoplasmsHematologic NeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-Cell

Study Officials

  • Leonard B. Saltz, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2002

First Posted

July 8, 2003

Study Start

April 1, 2002

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)