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Status:

UNKNOWN

Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 cell...

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. * D...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00083096

    Start Date

    March 1 2004

    Last Update

    February 10 2015

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, France, 21079

    2

    Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, France, 44805

    3

    Centre Hospitalier Universitaire Vaudois

    Lausanne, Switzerland, CH-1011