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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Dacarbazine; Irinotecan; Temozolomide

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