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Recurrent GlioblastomaPhase 2CLBH589CNCT01115036

A Panobinostat Presurgery

A Phase 2 study testing panobinostat in people with Recurrent Glioblastoma, run by Duke University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In the current study, the investigators will evaluate intratumoral pharmacodynamic and pharmacokinetic data associated with the administration of the HDACI, Panobinostat, among recurrent GBM patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
panobinostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2010to Apr 2012
Phase
Phase 2
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

  • Patient age is ≥ 18 years
  • Histologically-confirmed grade 4 malignant glioma patients;
  • Candidate for surgical resection of tumor;
  • No more than 3 prior episodes of progressive disease;
  • An interval of at least 4 weeks between prior surgical resection or two weeks from stereotactic biopsy;
  • An interval of at least 12 weeks from the end of prior radiotherapy unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field, or there are progressive changes on MRI on at least two consecutive MRI scans at least four weeks apart, or there is biopsy-proven tumor progression;
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  • An interval of at least 4 weeks from prior chemotherapy (6 weeks for nitrosoureas) or investigational agent, unless the patient has recovered from all anticipated toxicities associated with that therapy;
  • Karnofsky * 70%;
  • Hemoglobin ≥ 9 g/dL, ANC > 1,500 cells/*l, platelets > 150,000 cells/*l ;
  • Serum creatinine < 1.5 mg/dl or 24-hour creatinine clearance ≥ 50 ml/min, serum SGOT and bilirubin < 1.5 times upper limit of normal; total serum calcium (corrected for serum albumin) or ionized calcium ≥ LLN; serum potassium ≥ LLN; serum sodium ≥ LLN; serum albumin ≥ LLN or 3g/dl;
  • Clinically euthyroid (Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism);
  • Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal;
  • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed;

Who cannot join

  • Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
  • Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment;
  • Use of CYP-3A inducing anti-epileptics (phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, phenobarbitol, primidone);
  • Pregnancy or breast feeding;
  • Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids;
  • Active infection requiring intravenous antibiotics;
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  • Prior bevacizumab within 6 weeks of study enrollment;
  • Therapeutic anti-coagulation with warfarin, aspirin, non-steroidal anti-inflammatory drugs or clopidogrel;
  • Impaired cardiac function including any one of the following:
  • Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute), QTcF > 450 msec on screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block);
  • Presence of atrial fibrillation (ventricular heart rate >100 bpm);
  • Previous history angina pectoris or acute MI within 6 months;
  • Congestive heart failure (New York Heart Association functional classification III-IV) or baseline MUGA/Echo shows LVEF < 45%;
  • Uncontrolled hypertension;
  • Concomitant use of drugs with a risk of causing Torsades de pointes (See Table 14-1);
  • Patients with unresolved diarrhea ≥ grade 2;
  • Patients with ≥ grade 2 peripheral neuropathy;
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
  • Other concurrent severe and/or uncontrolled medical conditions;
  • Concomitant use of any anti-cancer therapy or radiation therapy;
  • Patients with a history of another primary malignancy within 5 years other than curatively treated carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin;
  • Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required;
  • Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
  • Women of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of oral panobinostat;
  • Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment. One of these methods must be a condom.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase II Study of Panobinostat (LBH589) for Recurrent Glioblastoma (GBM) Undergoing Planned Surgical Resection

In the current study, the investigators will evaluate intratumoral pharmacodynamic and pharmacokinetic data associated with the administration of the HDACI, Panobinostat, among recurrent GBM patients. In addition, this study will evaluate the safety and tolerability of this agent, as well as evidence of anti-tumor activity in the patient population.

Read the detailed description

This study will enroll a maximum of 24 subjects with recurrent GBM who are scheduled for planned debulking craniotomy.

After screening and enrollment on the study, subjects will receive 20mg panobinostat 3 times a week for one week prior to surgery. Within 2-6 weeks of resection, subjects will resume panobinostat at 20mg panobinostat 3 times per week.

The primary endpoint will be 6-month progression-free survival. Each cycle of therapy will be 28 days. All subjects will be assessed after every other cycle of therapy. Subjects will remain on study therapy for at least one year unless they develop progressive disease, unacceptable toxicity, non-compliance with study procedures or withdraw consent. Patients may continue treatment with oral panobinostat until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator.

Being tested
panobinostat
Keywords
glioblastoma, recurrent, surgical resection
Medical subject headings
Glioblastoma, Recurrence

What participants receive

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

  • panobinostatDrug

    Also called LBH589

    Oral panobinostat will be administered at 20mg by mouth 3 times a week one week prior to surgical resection. Within 2-6 weeks of resection, patients will resume panobinostat at 20mg 3 times per week. A cycle will be 28 days.

Study groups in NCT01115036
Study groupRoleWhat they receive
panobinostatExperimentalNot described
Receives: Drug: panobinostat

What is being measured

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

  1. Anti-tumor Activity as Measured by Percentage of Patients Who Remain Progression-free after Six Months

    The primary objective will be to determine the anti-tumor activity of panobinostat among recurrent GBM patients as measured by the percentage of patients who remain progression-free after 6 months of therapy (PFS-6)

    Measured: 18 months

Secondary outcomes (3)

  1. Safety Evaluation of Panobinostat

    A secondary objective is to further evaluate the safety of panobinostat in recurrent GBM patients

    Measured: 24 months

  2. Evaluation of Intratumoral Pharmacokinetics and Pharmacodynamics of Panobinostat

    A secondary objective is to evaluate the intratumoral pharmacokinetics and pharmacodynamics of panobinostat among recurrent GBM patients scheduled for surgical debulking

    Measured: 24 months

  3. Evaluation of Systemic Pharmacokinetics

    A secondary objective is to evaluate the systemic pharmacokinetics of panobinostat among recurrent GBM patients.

    Measured: 24 months

Timeline

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

  1. First posted3 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2011 (estimated)
  4. Study completionApr 2012 (estimated)

Why it stopped: No subjects were enrolled on this study, so study was closed and IND withdrawn.

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01115036
Sponsor's protocol ID
Pro00020612
Acronym
CLBH589C
Status last verified
Dec 2011
First submitted
30 Apr 2010
Last updated
19 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing panobinostat in people with Recurrent Glioblastoma, run by Duke University 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 13 inclusion and 25 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: withdrawn, as of the sponsor's last update on 19 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 withdrawn before enrolling participants, so there are no results.

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?

Anti-tumor Activity as Measured by Percentage of Patients Who Remain Progression-free after Six Months (time frame: 18 months). 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 NCT01115036.

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 19 Jun 2013.

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