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A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme


- Compare overall survival of patients with newly diagnosed supratentorial glioblastoma
multiforme treated with radiotherapy and temozolomide followed by temozolomide and
irinotecan with historical controls from the RTOG database.

- Determine the short- and long-term toxicity of this regimen in these patients.

- Determine progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6
weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7
days a week, for 6 weeks.

- Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of
chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral
temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year
in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- At least 8 weeks


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL*

- Hematocrit ≥ 30%* NOTE: *Transfusion allowed


- Bilirubin ≤ 0.5 mg/dL

- ALT or AST ≤ 2 times upper limit of normal


- Creatinine ≤ 1.5 mg/dL

- BUN ≤ 25 mg/dL


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-barrier contraception during and for 2
months after study participation


- 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


Biologic therapy

- No concurrent sargramostim (GM-CSF)


- 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


- No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields

- Prior radiotherapy for stage T1 glottic cancer allowed


- See Disease Characteristics

- Recovered from prior surgery


- No enzyme-inducing antiepileptic drugs within 14 days before the initiation of

- Concurrent non-enzyme-inducing antiepileptic drugs allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Frank S. Lieberman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

November 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult glioblastoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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