NCT00005634

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 suberoylanilide hydroxamic acid in treating patients who have advanced primary or metastatic solid tumors that have not responded to previous therapy.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2000

Shorter than P25 for phase_1 leukemia

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

January 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 17, 2003

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

May 2, 2000

Last Update Submit

June 18, 2013

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmProstate CancerSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

recurrent adult Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomaisolated plasmacytoma of boneextramedullary plasmacytomarefractory multiple myelomarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiasmall intestine lymphomarecurrent prostate cancerunspecified adult solid tumor, protocol specificchronic phase chronic myelogenous leukemiarefractory hairy cell leukemiachronic myelomonocytic leukemiarecurrent 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 lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiarecurrent mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

vorinostatDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed primary or metastatic malignancy refractory to standard therapy or for which no curative therapy exists No progressive metastatic disease requiring palliative therapy within 4 weeks of study Progressive disease Increase in preexisting lesions on imaging or physical examination Patients with sole progression criterion of increased biochemical marker (e.g., carcinoembryonic antigen or CA 15-3) or increased symptoms not eligible Prostate cancer must be either progressive metastatic disease on imaging studies or have rising PSA values Minimum of 3 rising PSA values obtained at least 1 week apart, or 2 rising PSA values more than 1 month apart, with at least a 25% overall increase Serum testosterone less than 50 ng/mL Must maintain castrate status No active CNS or epidural tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL AST no greater than 37 U/L PT no greater than 14 seconds Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No significant cardiac disease No New York Heart Association class III or IV heart disease Pulmonary: No severe debilitating pulmonary disease Other: No infection requiring IV antibiotic treatment No other severe medical problems that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Recovered from prior endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy to target lesions Surgery: Not specified Other: At least 4 weeks since other prior investigational anticancer drugs and recovered No concurrent ketoconazole in patients with prostate cancer

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

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellProstatic NeoplasmsHodgkin DiseaseLymphoma, T-Cell, CutaneousLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Chronic-PhaseLeukemia, Hairy CellLeukemia, Myelomonocytic, ChronicLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal Zone

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesLymphoma, T-CellLeukemia, MyeloidLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersBone Marrow DiseasesMyelodysplastic-Myeloproliferative DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

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

May 2, 2000

First Posted

December 17, 2003

Study Start

January 1, 2000

Primary Completion

October 1, 2002

Study Completion

October 1, 2002

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)