Status:
UNKNOWN
Arsenic Trioxide, Temozolomide, and Radiation Therapy in Treating Patients With Malignant Glioma That Has Been Removed By Surgery
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Cephalon
CTI BioPharma
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 dividin...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of arsenic trioxide and temozolomide when combined with radiotherapy in patients with resected supratentorial malignant glioma. (Phas...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00275067
Start Date
May 1 2005
End Date
May 1 2021
Last Update
February 25 2020
Active Locations (3)
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1
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States, 60611-2998
2
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
3
Edward Cancer Center
Naperville, Illinois, United States, 60540