Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI RTOG-0420 RTOG-0420, NCT00099125

Objectives

1. 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.
2. Determine the short- and long-term toxicity of this regimen in these patients.
3. Determine progression-free survival of patients treated with this regimen.

Entry Criteria

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• At least 8 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Overall survival
Short- and long-term toxicity
Progression-free survival

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.

Lieberman FS, Tsien C, Berkey B, et al.: Phase II trial of concomitant low dose temozolomide with external beam radiation (EBRT) followed by 12 months of temozolomide and irinotecan for newly diagnosed glioblastoma (GBM): preliminary results of RTOG 04-20. [Abstract] J Clin Oncol 24 (Suppl 18): A-1510, 2006.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Frank Lieberman, MD, Protocol chair		Ph: 412-692-2600 Email: liebermanf@upmc.edu
Christina Tsien, MD, Protocol co-chair		Ph: 734-936-4300; 800-865-1125

Registry Information
Official Title		A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
Trial Start Date		2004-11-11
Registered in ClinicalTrials.gov		NCT00099125
Date Submitted to PDQ		2004-08-20
Information Last Verified		2005-09-23
NCI Grant/Contract Number		CA21661

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