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Adult Nasal Type Extranodal NK/T-cell LymphomaPhase 1NCT01116154

Vorinostat and Lenalidomide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

A Phase 1 study testing lenalidomide, vorinostat and laboratory biomarker analysis in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by City of Hope Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lenalidomide, vorinostat and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
May 2010to Aug 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/ml within 10-14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control-one highly effective method and one additional effective method AT THE SAME TIME-at least 28 days she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
  • Able to take aspirin or low molecular weight heparin as prophylactic anticoagulation
  • Life expectancy greater than 3 months
  • Able to swallow enteral medications

Who cannot join

  • 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
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  • 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
  • Current therapeutic anti-coagulation
  • Any contraindication to safely using prophylactic anticoagulation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Phase I Study of the Combination of Lenalidomide With the Histone Deacetylase Inhibitor, Vorinostat in Hodgkin and Non Hodgkin's Lymphoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety and tolerability of the combination of lenalidomide and vorinostat.

II. To determine the maximum tolerated dose (MTD) and recommended dose of vorinostat and lenalidomide when given in combination in this patient population.

SECONDARY OBJECTIVES:

  1. To obtain preliminary data for response rate, time to response, response duration and time to progression (TTP) for vorinostat and lenalidomide when used in combination.

OUTLINE: This is a dose-escalation study of vorinostat.

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.

After completion of study treatment, patients are followed every 3 months.

Being tested
lenalidomide, vorinostat, laboratory biomarker analysis
Medical subject headings
Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Lymphoma, T-Cell, Peripheral, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given orally

  • vorinostatDrug

    Also called L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01116154
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: lenalidomide; Drug: vorinostat; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Following Cycle 1 of treatment

Secondary outcomes (7)

  1. Number of patients with Grade 3 or above adverse events

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

  2. Duration, intensity, and time to onset of toxicities

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

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

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

  4. Objective response rate

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

  5. Time to response

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

  6. Response duration

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

  7. Progression-free survival

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJul 2010
  4. Study completionAug 2010

Why it stopped: Sponsor withdrew support for the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01116154
Sponsor's protocol ID
08144
Other IDs
NCI-2010-00947
Status last verified
Dec 2010
First submitted
30 Apr 2010
Last updated
9 Dec 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lenalidomide, vorinostat and laboratory biomarker analysis in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor withdrew support for the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the Maximum Tolerated Dose and Dose-Limiting Toxicities of the combination of vorinostat and lenalidomide in this patient population (time frame: Following Cycle 1 of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01116154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2010.

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