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Brain and Central Nervous System TumorsPhase 1NCT00083096

Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas

A Phase 1 study testing lonafarnib and temozolomide in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving lonafarnib together with temozolomide may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
lonafarnib and temozolomide
How many people
30 participants
Where
3 sitesin 2 countries
Study dates
Mar 2004to Jun 2009
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary supratentorial glioma
  • Multifocal disease allowed
  • Recurrent disease after prior surgery and/or radiotherapy
  • Radiological evidence of increased and/or enhanced target lesion
  • Amenable to temozolomide therapy

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2 OR
  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL

Hepatic

  • Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
  • Transaminases < 2.5 times ULN
  • Bilirubin < 1.5 times ULN

Renal

  • Creatinine < 1.7 mg/dL

Cardiovascular

  • Cardiac function clinically normal
  • Normal 12-lead ECG
  • QTc ≤ 440 msec on ECG
  • No ischemic heart disease within the past 6 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No unstable systemic disease
  • No active uncontrolled infection
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
  • No other active or recurrent malignancy within the past 5 years except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent anticancer biologic agents

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for temozolomide)
  • Prior adjuvant chemotherapy allowed
  • No more than 1 prior chemotherapy regimen for recurrent disease
  • No other concurrent chemotherapy

Endocrine therapy

  • Concurrent corticosteroids allowed provided treatment remains at a stable or decreasing dose for at least 2 weeks

Radiotherapy

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • At least 3 months since prior surgery for primary brain tumor

Other

  • Concurrent anticonvulsants allowed
  • No other concurrent anticancer agents
  • No other concurrent investigational therapy

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

France2 sites

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

Other trials in France

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

About this study

Official title: Phase I Study Of SCH66336 (Lonafarnib), A Farnesyl Protein Transferase Inhibitor In Combination With Temozolomide In Gliomas

RATIONALE: Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving lonafarnib together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with temozolomide in treating patients with recurrent primary supratentorial glioma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and dose-limiting toxicity of lonafarnib when administered with temozolomide in patients with recurrent primary supratentorial gliomas.
  • Determine the safety and tolerability of this regimen in these patients.

Secondary

  • Determine the mechanism of action of lonafarnib in these patients.
  • Determine the pharmacodynamics and pharmacokinetics of this regimen in these patients.
  • Determine the activity of this regimen in these patients.
  • Determine the response to this regimen in patients who have measurable disease.

OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study of lonafarnib.

Patients receive oral temozolomide once daily on days 2-6 of course 1 and on days 1-5 of all subsequent courses. Patients also receive oral lonafarnib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of lonafarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experience dose-limiting toxicity. An additional 3 patients may be treated at the highest dose level achieved.

Patients are followed every 8 weeks for 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Being tested
lonafarnib, temozolomide
Keywords
recurrent adult brain tumor, adult mixed glioma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult pilocytic astrocytoma, adult anaplastic ependymoma, adult subependymoma, adult myxopapillary ependymoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult diffuse astrocytoma, adult subependymal giant cell astrocytoma, adult pineal gland astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma, Ependymoma, Glioma, Subependymal

What participants receive

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

What is being measured

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

  1. Dose-limiting toxicity and maximum tolerated dose of lonafarnib determined by CTCAE v3.0

Secondary outcomes (1)

  1. Response (complete [CR] or partial response [PR]) measured by McDonald's criteria at least 4 weeks after first documented response and every 8 weeks until disease progression or until start of another treatment

Timeline

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

  1. First posted17 May 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionJun 2009

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
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083096
Sponsor's protocol ID
EORTC-16027-26023
Other IDs
EORTC-16027, EORTC-26023, SPRI-P03174
Status last verified
Feb 2015
First submitted
14 May 2004
Last updated
10 Feb 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lonafarnib and temozolomide in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 3 sites in 2 countries.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Switzerland. 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?

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?

Dose-limiting toxicity and maximum tolerated dose of lonafarnib determined by CTCAE v3.0. 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 NCT00083096.

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 10 Feb 2015.

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