NCT00020579

Brief Summary

RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 in treating patients with advanced solid tumors or lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_1 cancer

Geographic Reach
1 country

3 active sites

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

March 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

7.1 years

First QC Date

July 11, 2001

Last Update Submit

March 14, 2012

Conditions

Cancer

Keywords

stage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomasmall intestine 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 lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaprimary central nervous system non-Hodgkin lymphomaintraocular lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic 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 lymphomamale breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent pancreatic cancerstage III pancreatic cancerrecurrent colon cancerstage III colon cancerstage IV colon cancerrecurrent rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorstage III ovarian epithelial cancerstage III ovarian germ cell tumorstage IV ovarian epithelial cancerstage IV ovarian germ cell tumorrecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumorrecurrent cervical cancerstage III cervical cancerstage IVA cervical cancerstage IVB cervical cancerrecurrent endometrial carcinomastage III endometrial carcinomastage IV endometrial carcinomafallopian tube cancerprimary peritoneal cavity cancerrecurrent uterine sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent vaginal cancerstage III vaginal cancerstage IVA vaginal cancerstage IVB vaginal cancerrecurrent vulvar cancerstage III vulvar cancerstage IV vulvar cancerrecurrent anal cancerstage IIIA anal cancerstage IIIB anal cancerstage IV anal cancerrecurrent esophageal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent gastric cancerstage III gastric cancerstage IV gastric cancerrecurrent extrahepatic bile duct cancerunresectable extrahepatic bile duct canceradvanced adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancerrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent basal cell carcinoma of the liprecurrent squamous cell carcinoma of the lip and oral cavitystage III basal cell carcinoma of the lipstage III squamous cell carcinoma of the lip and oral cavitystage IV basal cell carcinoma of the lipstage IV squamous cell carcinoma of the lip and oral cavityrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavitymetastatic parathyroid cancerrecurrent parathyroid cancerrecurrent salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent bladder cancerrecurrent gallbladder cancerstage III bladder cancerstage IV bladder cancerunresectable gallbladder cancerrecurrent renal cell cancerstage III renal cell cancerstage IV renal cell cancerstage III Wilms tumorstage IV Wilms tumorstage V Wilms tumormetastatic transitional cell cancer of the renal pelvis and ureterrecurrent transitional cell cancer of the renal pelvis and ureterregional transitional cell cancer of the renal pelvis and ureteranterior urethral cancerposterior urethral cancerrecurrent urethral cancerrecurrent penile cancerstage III penile cancerstage IV penile cancerrecurrent prostate cancerstage III prostate cancerstage IV prostate cancermetastatic Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumormetastatic osteosarcomarecurrent osteosarcomarecurrent adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcomaclassic Kaposi sarcomaAIDS-related Kaposi sarcomarecurrent Kaposi sarcomastage III cutaneous T-cell non-Hodgkin lymphomaciliary body and choroid melanoma, medium/large sizeciliary body and choroid melanoma, small sizeextraocular extension melanomairis melanomarecurrent intraocular melanomarecurrent melanomastage III melanomastage IV melanomaextensive stage small cell lung cancerrecurrent non-small cell lung cancerrecurrent small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent thymoma and thymic carcinomaadvanced malignant mesotheliomarecurrent malignant mesotheliomarecurrent adrenocortical carcinomastage III adrenocortical carcinomastage IV adrenocortical carcinomametastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorregional gastrointestinal carcinoid tumordesmoid tumornewly diagnosed carcinoma of unknown primaryrecurrent carcinoma of unknown primaryundifferentiated carcinoma of unknown primarycarcinoma of the appendixrecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primaryrecurrent pituitary tumoradult anaplastic astrocytomaadult astrocytic tumorsadult diffuse astrocytomaadult pilocytic astrocytomaadult anaplastic oligodendrogliomaadult brain stem gliomaadult oligodendrogliomaadult mixed gliomaadult central nervous system germ cell tumoradult choroid plexus tumoradult craniopharyngiomaadult anaplastic ependymomaadult subependymomaadult medulloblastomaadult supratentorial primitive neuroectodermal tumor (PNET)adult ependymoblastomaadult ependymomaadult myxopapillary ependymomaadult anaplastic meningiomaadult meningeal hemangiopericytomaadult meningiomaadult papillary meningiomaadult grade I meningiomaadult grade II meningiomaadult grade III meningiomaadult pineal parenchymal tumorrecurrent adult brain tumorstage IV pancreatic cancerstage III thymomastage IVA thymomastage IVB thymoma

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicities and maximum tolerated dose

  • Pharmacology and pharmacokinetics

Secondary Outcomes (2)

  • Acetylation of histones in peripheral blood

  • Tumor response by CT scan every 12 weeks

Interventions

entinostatDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy that is metastatic or unresectable and for which no effective standard curative or palliative therapy exists * Brain metastases allowed provided both of the following criteria are met: * Received treatment for the brain metastases * Stable for ≥ 6 months without steroids or antiseizure medications PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 50-100% Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (≤ 3 mg/dL for patients with Gilbert's syndrome) * AST/ALT no greater than 2.5 times ULN * Albumin at least 75% of lower limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * Cardiac ejection fraction normal by MUGA * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Adequate oral intake * No weight loss of more than 10% of actual body weight within the past 2 months * No history of allergic reaction to compounds of similar chemical or biological composition to study drug * No other uncontrolled illness * No ongoing or active infection * No seizure disorder * No psychiatric illness or social situation that would preclude study compliance * No acute or chronic gastrointestinal conditions (e.g., peptic ulcer or colitis) within the past 2 months that would interfere with drug tolerance or absorption * Willing and able to self-administer and document doses of MS-275 PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior anticancer vaccine therapy and recovered * No concurrent immunotherapy Chemotherapy: * At least 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * At least 8 weeks since prior UCN-01 and recovered * No concurrent chemotherapy Endocrine therapy: * At least 4 weeks since prior anticancer hormonal therapy (except gonadotropin-releasing hormone \[GnRH\] agonists) and recovered * Concurrent corticosteroids for physiological replacement, as antiemetic therapy, or for an ongoing condition allowed * Must be on a stable dose during the past 4 weeks * No concurrent anticancer hormonal therapy except GnRH agonists for noncastrated patients with prostate cancer Radiotherapy: * At least 4 weeks since prior anticancer radiotherapy and recovered * No concurrent radiotherapy * Concurrent localized radiotherapy to a single lesion allowed if the patient achieves at least a partial response Surgery: * At least 3 weeks since prior major surgery Other: * No other concurrent investigational or commercial antineoplastic therapies

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

Sponsors & Collaborators

Study Sites (3)

National Naval Medical Center

Bethesda, Maryland, 20889-5000, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Ryan QC, Headlee D, Sparreboom A, et al.: A phase I trial of an oral histone deacetylase inhibitor, MS-275, in advanced solid tumor and lymphoma patients. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-802, 2003.

    RESULT

MeSH Terms

Conditions

NeoplasmsLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellBreast Neoplasms, MaleBreast NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsCarcinoma, Ovarian EpithelialTesticular NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsFallopian Tube NeoplasmsVaginal NeoplasmsVulvar NeoplasmsAnus NeoplasmsEsophageal NeoplasmsStomach NeoplasmsBile Duct NeoplasmsCarcinoma, HepatocellularSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactoryParathyroid NeoplasmsSalivary Gland NeoplasmsUrinary Bladder NeoplasmsGallbladder NeoplasmsCarcinoma, Renal CellWilms TumorUrethral NeoplasmsPenile NeoplasmsProstatic NeoplasmsNeuroectodermal Tumors, Primitive, PeripheralOsteosarcomaSarcomaAIDS-related Kaposi sarcomaSarcoma, KaposiUveal MelanomaMelanomaCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaThymomaMesothelioma, MalignantAdrenocortical CarcinomaDesmoid TumorsNeoplasms, Unknown PrimaryAppendiceal NeoplasmsPituitary NeoplasmsAstrocytomaOligodendrogliomaGliomaChoroid Plexus NeoplasmsCraniopharyngiomaEpendymomaGlioma, SubependymalMedulloblastomaNeuroectodermal Tumors, PrimitiveMeningiomaPinealomaBrain Neoplasms

Interventions

entinostat

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteLymphadenopathyLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinomaNeoplasms, Glandular and EpithelialOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesFallopian Tube DiseasesVaginal DiseasesVulvar DiseasesAnus DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesAdenocarcinomaLiver NeoplasmsLiver DiseasesCarcinoma, Squamous CellNeuroblastomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParathyroid DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesGallbladder DiseasesKidney NeoplasmsKidney DiseasesNeoplasms, Complex and MixedNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrethral DiseasesPenile DiseasesProstatic DiseasesNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms, Vascular TissueNeuroendocrine TumorsNevi and MelanomasUveal NeoplasmsEye DiseasesUveal DiseasesSkin NeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesThymus NeoplasmsMesotheliomaAdenomaNeoplasms, MesothelialPleural NeoplasmsAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesFibromaNeoplasms, Fibrous TissueNeoplasm MetastasisNeoplastic ProcessesCecal NeoplasmsCecal DiseasesHypothalamic NeoplasmsSupratentorial NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesHypothalamic DiseasesPituitary DiseasesCerebral Ventricle NeoplasmsMeningeal Neoplasms

Study Officials

  • Shivaani Kummar, MD

    NCI - Medical Oncology Branch

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Primary Completion

April 1, 2008

Study Completion

October 1, 2008

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(3)