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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)

Phase 1
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

Thank you

Trial Information

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)


- Determine the maximum tolerated dose of arsenic trioxide when administered sequentially
with temozolomide during radiotherapy in patients with newly diagnosed glioblastoma

- Determine the dose-limiting toxicities of this regimen in these patients.

OUTLINE: This is a dose-escalation study of arsenic trioxide.

Patients undergo radiotherapy (may be intensity-modulated) on days 1-5. Patients also
receive arsenic trioxide IV over 1-2 hours on days 1-5, and oral temozolomide on days 1-7.
Treatment with radiotherapy, arsenic trioxide, and temozolomide repeats every week for up to
6 weeks in the absence of disease progression or unacceptable toxicity.

Patients may then receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for
up to 12 courses in the absence of disease progression.

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of arsenic trioxide

Safety Issue:


Principal Investigator

Jana Portnow, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

February 2009

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult gliosarcoma
  • adult mixed glioma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



City of Hope Comprehensive Cancer Center Duarte, California  91010