NCT01116154

Brief Summary

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vorinostat together with lenalidomide may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide in treating patients with relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

April 30, 2010

Last Update Submit

December 8, 2010

Conditions

Adult Nasal Type Extranodal NK/T-cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaCutaneous B-cell Non-Hodgkin LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaIntraocular LymphomaNodal Marginal Zone B-cell LymphomaPeripheral T-Cell LymphomaPost-transplant Lymphoproliferative DisorderRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaSmall Intestine LymphomaSplenic Marginal Zone LymphomaTesticular LymphomaWaldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Assessment of the Maximum Tolerated Dose and Dose-Limiting Toxicities of the combination of vorinostat and lenalidomide in this patient population

    Following Cycle 1 of treatment

Secondary Outcomes (7)

  • Number of patients with Grade 3 or above adverse events

    Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug

  • Duration, intensity, and time to onset of toxicities

    Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug

  • AE, laboratory safety assessments, ECOG, ECGs, vital signs, transfusions, hospital days, and antibiotic use

    Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug

  • Objective response rate

    Every nine weeks on therapy after 2 years a minimum of every 6 months

  • Time to response

    Every nine weeks on therapy after 2 years a minimum of every 6 months

  • +2 more secondary outcomes

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral vorinostat twice daily on days 1-14 and oral lenalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: lenalidomideDrug: vorinostatOther: laboratory biomarker analysis

Interventions

lenalidomideDRUG

Given orally

Also known as: CC-5013, IMiD-1, Revlimid
Arm I
vorinostatDRUG

Given orally

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understand and voluntarily sign an informed consent form
  • Able to adhere to the study visit schedule and other protocol requirements
  • Patients must have a history of biopsy-documented Hodgkin or non-Hodgkin lymphoma (either B or T cell) and with relapsed or refractory disease after at least one prior line of therapy
  • All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
  • Patients must have measurable disease by CT scan; PET scans are desirable but not mandatory, so that patients with negative PET scans but measurable disease by CT are eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at study entry
  • Patients may be enrolled who relapse after autologous stem cell transplant or after allogeneic transplant; they must have no active related infections (i.e., fungal or viral), no acute graft versus host disease (GvHD) of any grade, and no chronic GvHD other than mild skin, or, or ocular GvHD not requiring systemic immunosuppression
  • Laboratory test results within these ranges:
  • Absolute neutrophil count \>= 1,000/mm\^3
  • Platelet count \>= 75,000/mm\^3
  • Serum creatinine =\< 1.5 mg/dL
  • Total bilirubin \<= 1.5 mg/dL (however, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible)
  • AST (SGOT) =\< 2 x upper limit of normal (ULN)
  • ALT (SGPT) =\< 2 x ULN
  • Disease free of prior malignancies for \>= 5 years with exception of currently treated blast cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • +5 more criteria

You may not qualify if:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Pregnant or breast-feeding females; lactating females must agree not to breastfeed while taking lenalidomide
  • Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Use of any other experimental drug or therapy with 28 days of baseline
  • Known sensitivity to thalidomide or histone deacetylating agents
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
  • Any prior use of lenalidomide, vorinostat, or other histone deacetylase inhibitors other than valproic acid, which must be stopped 2 weeks prior to study unless being used for seizure control
  • Concurrent use of other anti-cancer agents or treatments
  • Known positive for HIV or infectious hepatitis type B or C
  • Patients with known brain/CNS metastases
  • Patients with feeding tubes
  • Any history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Any current infection requiring the use of antibiotic, antiviral, or antifungal medication
  • Any uncontrolled dysrhythmias
  • Baseline QTcF interval \> 500 msec in the absence of correctable electrolyte imbalance or any patient with a congenital history of QTc prolongation
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyIntraocular LymphomaLymphoma, B-Cell, Marginal ZoneLymphoma, T-Cell, PeripheralBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom Macroglobulinemia

Interventions

LenalidomideVorinostat

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathyEye NeoplasmsNeoplasms by SiteLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAnilidesAmidesAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy Acids

Study Officials

  • Leslie Popplewell

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 4, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

December 9, 2010

Record last verified: 2010-12

Locations

US(1)