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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00099125
Enrollment
170
Registered
2004-12-09
Start date
2004-11-30
Completion date
2013-11-30
Last updated
2014-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma

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 they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.

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 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.

Interventions

DRUGirinotecan hydrochloride
DRUGtemozolomide
PROCEDUREadjuvant therapy
RADIATIONradiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Radiation Therapy Oncology Group
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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 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

Design outcomes

Primary

MeasureTime frame
Overall survivalFrom registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.

Secondary

MeasureTime frame
Progression-free survivalFrom randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026