Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study of the Combination of Radiation Therapy (RT), Arsenic Trioxide (ATO) and Temozolomide (TMZ) in Patients With Newly-Diagnosed Glioblastoma Multiforme (GBM)
Verified date | August 2010 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 cells, either by killing the cells or by stopping them from dividing.
Arsenic trioxide and temozolomide may also make tumor cells more sensitive to radiation
therapy. Giving radiation therapy together with combination chemotherapy may kill more tumor
cells.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide
when given together with temozolomide and radiation therapy in treating patients with newly
diagnosed high-grade glioma.
Status | Completed |
Enrollment | 18 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of arsenic trioxide | Yes | ||
Primary | Dose-limiting toxicities as measured by CTCAE version 3.0 | Yes |
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