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Status:

COMPLETED

Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so...

Detailed Description

OBJECTIVES: * Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision
  • No gliomas graded less than glioblastoma multiforme
  • No recurrent malignant gliomas
  • No tumor foci below the tentorium or beyond the cranial vault
  • Study therapy must begin ≤ 5 weeks after surgery
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-1
  • Life expectancy
  • At least 8 weeks
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10 g/dL\*
  • Hematocrit ≥ 30%\* NOTE: \*Transfusion allowed
  • Hepatic
  • Bilirubin ≤ 0.5 mg/dL
  • ALT or AST ≤ 2 times upper limit of normal
  • Renal
  • Creatinine ≤ 1.5 mg/dL
  • BUN ≤ 25 mg/dL
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception during and for 2 months after study participation
  • No AIDS
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
  • No other major medical illness or psychiatric impairment that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent sargramostim (GM-CSF)
  • Chemotherapy
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry
  • Radiotherapy
  • No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields
  • Prior radiotherapy for stage T1 glottic cancer allowed
  • Surgery
  • See Disease Characteristics
  • Recovered from prior surgery
  • Other
  • No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan
  • Concurrent non-enzyme-inducing antiepileptic drugs allowed

Exclusion

    Key Trial Info

    Start Date :

    November 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2013

    Estimated Enrollment :

    170 Patients enrolled

    Trial Details

    Trial ID

    NCT00099125

    Start Date

    November 1 2004

    End Date

    November 1 2013

    Last Update

    January 24 2014

    Active Locations (118)

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    Page 1 of 30 (118 locations)

    1

    Foundation for Cancer Research and Education

    Phoenix, Arizona, United States, 85013

    2

    Providence Saint Joseph Medical Center - Burbank

    Burbank, California, United States, 91505

    3

    Saint Agnes Medical Center

    Fresno, California, United States, 93720

    4

    Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, United States, 92354