NCT00083096

Brief 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. 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.

Trial Health

60
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

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2004

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

5.3 years

First QC Date

May 14, 2004

Last Update Submit

February 9, 2015

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult mixed gliomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult glioblastomaadult pilocytic astrocytomaadult anaplastic ependymomaadult subependymomaadult myxopapillary ependymomaadult oligodendrogliomaadult giant cell glioblastomaadult gliosarcomaadult diffuse astrocytomaadult subependymal giant cell astrocytomaadult pineal gland astrocytoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

lonafarnibDRUG
temozolomideDRUG

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGliomaAstrocytomaOligodendrogliomaGlioblastomaEpendymomaGlioma, SubependymalGliosarcoma

Interventions

lonafarnibTemozolomide

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mario Campone, MD

    Centre Regional Rene Gauducheau

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 17, 2004

Study Start

March 1, 2004

Primary Completion

June 1, 2009

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

FR(2)CH(1)