Status:
COMPLETED
Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the growth of tumor cell...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of arsenic trioxide when administered sequentially with temozolomide during radiotherapy in patients with newly diagnosed glioblastoma multiforme. *...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Newly diagnosed grade III or IV glioma including any of the following:
- Glioblastoma
- Anaplastic astrocytoma
- Gliosarcoma
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- Measurable or nonmeasurable disease
- No more than 5 weeks since prior brain surgery
- Recovered from surgery, post- operative infection, and other complications
- Preoperatively and postoperatively diagnostic contrast-enhanced MRI or CT scan of the brain performed prior to radiation therapy
- Patients diagnosed by stereotactic biopsy do not require the postoperative scan
- PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 60%
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.0 mg/dL
- AST ≤ 4.0 times ULN
- No prolonged QT interval \> 460 milliseconds on baseline electrocardiogram in the presence of normal serum potassium and magnesium
- No uncontrolled electrolyte imbalance (i.e., sodium \< 132 mmol/L, potassium \< 3.5 mEq/dL, magnesium \< 1.7 mg/dL)
- No history of torsades de pointes type of ventricular arrhythmia
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No medical or psychiatric illness that, in the investigator's opinion, could potentially preclude the completion of study therapy
- No HIV positivity
- No active connective tissue disorders (e.g., lupus or scleroderma) that, in the investigator's opinion, may put the patient at high risk for radiation toxicity
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior brain radiotherapy or chemotherapy for brain tumor
- Concurrent corticosteroids to control cerebral edema allowed provided dose is stable or decreasing for the past 5 days
- No concurrent or plan to receive drugs that are known to prolong the QT interval
- No prior radiation to the head or neck (except for T1 glottic cancer) resulting in overlap of radiation fields
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00720564
Start Date
April 1 2008
End Date
February 1 2009
Last Update
August 11 2010
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000