Arsenic Trioxide, Temozolomide, and Radiation Therapy in Treating Patients With Malignant Glioma That Has Been Removed By Surgery

• Status: Active, not recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving arsenic trioxide and temozolomide together with radiation therapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide and temozolomide when given together with radiation therapy and to see how well they work in treating patients with malignant glioma that has been removed by surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: Cephalon; CTI BioPharma
• Treatments: Arsenic Trioxide; Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed supratentorial malignant glioma of 1 of the following types:

• Glioblastoma multiforme

• Gliosarcoma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic mixed gliomas

• Anaplastic gliomas not otherwise specified

• Has undergone surgical resection of tumor

• Patients with biopsy only are eligible

• Evaluable or measurable disease following resection of recurrent tumor is not mandated for entry into the study

• No brain metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Life expectancy > 3 months

• WBC > 3,000/mm^3

• Absolute neutrophil count > 2,000/mm^3

• Platelet count > 100,000/mm^3

• Hemoglobin > 10 g/dL (eligibility level for hemoglobin may be reached by transfusion)

• Creatinine ≤ 1.5 mg/dL

• Bilirubin ≤ 2 mg/dL

• Transaminases ≤ 2 times the upper limit of normal

• Serum potassium* > 4.0 mEq/dL

• Serum magnesium* > 1.8 mg/dL NOTE: *If these serum electrolytes are below the specified limits on the baseline laboratory tests, supplemental electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No second-degree heart block

• QT interval ≤ 460 msec

• No other malignancy within the past 3 years except curatively treated carcinoma in situ or basal cell carcinoma of the skin

• Patients who cannot undergo MRI are not eligible for this study

• No other serious concurrent infection or other medical illness that would jeopardize the ability of the patient to receive the therapy in this protocol with reasonable safety

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Patients must have recovered from the effects of surgery prior to the start of treatment (10-14 days minimum) and be maintained on a stable corticosteroid regimen for 5 days

• Concurrent glucocorticoid therapy allowed at the smallest effective dose

• Patients must be on non-enzyme-inducing anti-convulsants to minimize any drug reaction

• No prior radiation therapy, chemotherapy, immunotherapy, therapy with biologic agents (including immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy), or hormonal therapy for their brain tumor