NCT00045006

Brief Summary

RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid 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 Jul 2001

Longer than P75 for phase_1 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, 2001

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 30, 2013

Status Verified

October 1, 2003

Enrollment Period

4.4 years

First QC Date

September 6, 2002

Last Update Submit

May 29, 2013

Conditions

Cancer

Keywords

acute undifferentiated leukemiade novo myelodysplastic syndromesborderline ovarian surface epithelial-stromal tumorovarian sarcomaovarian stromal cancerpreviously treated myelodysplastic syndromesprolymphocytic leukemiarecurrent adult Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult diffuse large cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent bladder cancerrecurrent breast cancerrecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent metastatic squamous neck cancer with occult primaryrecurrent mycosis fungoides/Sezary syndromerecurrent non-small cell lung cancerrecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent prostate cancerrecurrent renal cell cancerrefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesstage III multiple myelomastage III mycosis fungoides/Sezary syndromestage III ovarian germ cell tumorstage IV mycosis fungoides/Sezary syndromestage IV ovarian germ cell tumorunspecified adult solid tumor, protocol specificstage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage III bladder cancerstage IV bladder cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerstage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerstage III oropharyngeal cancerstage IV oropharyngeal cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerstage III prostate cancerstage IV prostate cancerstage III renal cell cancerstage IV renal cell cancerstage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent salivary gland cancerstage IV salivary gland cancerstage III salivary gland cancerrecurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent 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 squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent 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 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 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 cavityrecurrent basal cell carcinoma of the lipstage III basal cell carcinoma of the lipstage IV basal cell carcinoma of the liprecurrent mucoepidermoid carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavityatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablemale breast cancer

Interventions

vorinostatDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * One of the following diagnoses: * Histologically confirmed advanced primary or metastatic solid tumor, including, but not limited to, the following: * Androgen-independent prostate cancer * Breast cancer * Ovarian cancer * Head and neck cancer * Non-small cell lung cancer * Bladder cancer * Kidney cancer * Diagnosis of lymphoma, multiple myeloma, leukemia, or myelodysplastic syndromes (MDS), including, but not limited to, the following: * Intermediate-grade or follicular non-Hodgkin's lymphoma * Hodgkin's lymphoma * Patients with lymphoma or multiple myeloma must be ineligible for peripheral blood stem cell transplantation * For patients with solid tumors (except prostate cancer): * Disease progression based on development of new lesions or an increase in pre-existing lesions * Biochemical marker increase must not be sole criterion for disease progression * For prostate cancer patients only: * Disease progression based on rising prostate-specific antigen (PSA) values, transaxial imaging, or radionuclide scans * Increase in disease-related symptoms must not be sole manifestation of progression * Patients receiving an antiandrogen as part of first-line hormonal therapy must show disease progression off of the antiandrogen prior to study * Biochemical progression (at least 25% increase over range of values) defined as 1 of the following: * Rising PSA documented by at least 3 consecutive measurements obtained at least 1 week apart * Rising PSA documented by at least 2 consecutive measurements obtained more than 1 month apart * PSA at least 4 ng/mL * Testosterone no greater than 50 ng/mL * If no prior orchiectomy, must maintain castrate levels of testosterone * Disease must be refractory to standard therapy or for which no curative therapy exists * No active CNS or epidural tumors * Hormone receptor status: * Not specified NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 (patients with solid tumors) * Platelet count greater than 25,000/mm\^3 (patients with hematologic malignancy) * Absolute neutrophil count at least 500/mm\^3 (patients with hematologic malignancy) Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 3 times ULN * PT no greater than 15 seconds Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No New York Heart Association class III or IV heart disease Pulmonary * No severe debilitating pulmonary disease Other * No infection requiring IV antibiotics * No other severe medical problems that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * At least 4 weeks since prior chemotherapy Endocrine therapy * See Disease Characteristics * At least 4 weeks since prior ketoconazole * At least 2 weeks since prior steroids for patients with lymphoma * Concurrent gonadotropin-releasing hormone analogs or diethylstilbestrol to maintain castrate levels of testosterone allowed for prostate cancer patients * No concurrent ketoconazole Radiotherapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy to sole measurable lesion Surgery * See Disease Characteristics * No concurrent surgery Other * Recovered from all prior therapy * At least 4 weeks since prior palliative therapy for solid tumor patients with progressive metastatic disease (if present) * At least 4 weeks since prior investigational anticancer therapeutic drugs * At least 2 weeks since prior conventional cytotoxic therapy for patients with leukemia or MDS * At least 4 weeks since prior investigational therapy for patients with leukemia or MDS * No other concurrent investigational drugs * No other concurrent anticancer agents

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

NeoplasmsLeukemia, Biphenotypic, AcuteLeukemia, ProlymphocyticHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinUrinary Bladder NeoplasmsBreast NeoplasmsLymphoma, T-Cell, CutaneousLymphoma, FollicularMycosis FungoidesSezary SyndromeCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialProstatic NeoplasmsCarcinoma, Renal CellLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaOropharyngeal NeoplasmsSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactoryLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersBreast Neoplasms, Male

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphomaLeukemia, MyeloidLymphoma, B-CellUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphoma, T-CellCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesAdenocarcinomaKidney NeoplasmsKidney DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth NeoplasmsMouth DiseasesSalivary Gland DiseasesCarcinoma, Squamous CellNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMyelodysplastic-Myeloproliferative DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Study Officials

  • William K. Kelly, DO

    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

September 6, 2002

First Posted

January 27, 2003

Study Start

July 1, 2001

Primary Completion

December 1, 2005

Study Completion

July 1, 2008

Last Updated

May 30, 2013

Record last verified: 2003-10

Locations

US(1)