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Adult Grade III Lymphomatoid GranulomatosisPhase 1NCT00348985

PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

A Phase 1 study testing belinostat, bortezomib and pharmacological study in people with Adult Grade III Lymphomatoid Granulomatosis and Anaplastic Large Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of PXD101 and bortezomib in treating patients with advanced solid tumors or lymphomas. PXD101 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
belinostat, bortezomib and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
Mar 2006to Jan 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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed solid tumor or lymphoma that is refractory to standard therapy or for which no standard therapy exists
  • No active, untreated, or symptomatic brain metastases
  • Patients with treated brain metastases are eligible provided metastasis are stable and the patient is off all steroids and anticonvulsants
  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • WBC ≥ 3,000/mm^3
Show all 42Show fewer
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101, bortezomib, boron, or mannitol
  • No peripheral neuropathy > grade 1
  • No uncontrolled intercurrent illness, including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Psychiatric illness or social situation that would preclude study requirements
  • No significant cardiovascular disease, including any of the following:
  • Myocardial infarction within the past 6 months
  • New York Heart Association class III-IV heart failure
  • Unstable angina pectoris
  • Uncontrolled hypertension
  • Condition requiring antiarrhythmic therapy
  • Ischemic or severe valvular heart disease
  • Acute ischemia or active conduction system abnormalities by ECG
  • No marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval > 500 msec), long QT syndrome, or required use of concurrent medication during PXD101 administration that may cause torsade de pointes
  • No severe medical or psychiatric problems of that would preclude study compliance
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin C)
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 2 weeks since prior palliative radiotherapy to sites involving < 35% of bone marrow reserve
  • At least 4 weeks since prior investigational agents
  • At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor
  • No prior stem cell or bone marrow transplantation
  • No concurrent radiotherapy or immunotherapy
  • No concurrent hormonal therapy
  • Luteinizing hormone-releasing hormone agonists, selective estrogen receptor modulators, or aromatase inhibitors as chronic maintenance therapy allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado

    Denver, Colorado, 80217-3364

Other trials in United States

About this study

Official title: A Phase 1 Study of PXD101 in Combination With Bortezomib (PS-341) in Patients With Advanced Solid Tumors and Lymphoma

This phase I trial is studying the side effects and best dose of PXD101 and bortezomib in treating patients with advanced solid tumors or lymphomas. PXD101 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PXD101 may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving PXD101 together with bortezomib may kill more cancer cells.

Read the detailed description

OBJECTIVES:

  1. Evaluate the safety profile and determine the maximum tolerated dose of PXD101 in combination with bortezomib in patients with advanced solid tumors or lymphomas.

II. Determine the pharmacokinetics of the combination of PXD101 and bortezomib in these patients.

III. Evaluate selected biomarkers of drug effect in these patients. IV. Evaluate the activity of this regimen, in terms of objective response rate, in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive PXD101 IV over 30 minutes on days 1-5 and bortezomib IV on days 1, 4, 8, and 11 (2, 5, 8, and 11 during course 1). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-9 patients receive escalating doses of bortezomib and PXD101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Blood is collected at baseline and periodically during course 1 of study treatment for pharmacokinetic studies.

After completion of study treatment, patients are followed periodically for 4 weeks.

Being tested
belinostat, bortezomib, pharmacological study
Medical subject headings
Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hodgkin Disease

What participants receive

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

Study groups in NCT00348985
Study groupRoleWhat they receive
PXD101 in Combination with Bortezomib (PS-341)ExperimentalPatients receive PXD101 IV over 30 minutes on days 1-5 and bortezomib IV on days 1, 4, 8, and 11 (2, 5, 8, and 11 during course 1).
Receives: Drug: belinostat; Drug: bortezomib; Other: pharmacological study

What is being measured

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

  1. Maximum tolerated dose of PXD101 in combination with bortezomib

    Defined as the dose level below that which results in drug-related dose limiting toxicity (DLT) in >= 2 of 6 new patients.

    Measured: Day 21

  2. Frequency and severity of treatment-related adverse events graded per NCI CTCAE version 3.0

    Measured: Day 21

  3. Changes in biological markers (p21, cleaved PARP, IkB, p65 Rel A, p-AKT, p-ERK and apoptosis) from pre- to post-treatment

    Measured: Baseline and day 21

  4. Objective response rate

    Measured: 4 weeks

Secondary outcomes (1)

  1. Pharmacokinetics of the combination of PXD101 with bortezomib

    Measured: Baseline, end of infusion, then 15 minutes, 30 minutes, 1, 2, 4 and 6 hours from the end of infusion (days 1 and 2)

Timeline

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

  1. First posted6 Jul 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionJan 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00348985
Sponsor's protocol ID
NCI-2009-01052
Other IDs
COMIRB 05-0705, UCHSC-COMIRB-05-0705, UCHSC-05-0705, NCI-7281, CDR0000476293, U01CA099176
Status last verified
May 2013
First submitted
5 Jul 2006
Last updated
3 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing belinostat, bortezomib and pharmacological study in people with Adult Grade III Lymphomatoid Granulomatosis and Anaplastic Large Cell Lymphoma, run by National Cancer Institute (NCI) 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 42 inclusion and 0 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: finished, as of the sponsor's last update on 3 May 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose of PXD101 in combination with bortezomib (time frame: Day 21). The study lists 4 primary outcomes in all. 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 NCT00348985.

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 3 May 2013.

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