Back to resultsRadiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma
Primary Purpose
Brain and Central Nervous System Tumors
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
temozolomide
adjuvant therapy
intensity-modulated radiation therapy
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult gliosarcoma, adult mixed glioma
Eligibility Criteria
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
Sites / Locations
- City of Hope Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Maximum tolerated dose of arsenic trioxide
Dose-limiting toxicities as measured by CTCAE version 3.0
Secondary Outcome Measures
Full Information
NCT ID
NCT00720564
First Posted
July 19, 2008
Last Updated
August 9, 2010
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00720564
Brief Title
Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult gliosarcoma, adult mixed glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Maximum tolerated dose of arsenic trioxide
Title
Dose-limiting toxicities as measured by CTCAE version 3.0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jana Portnow, MD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma
We'll reach out to this number within 24 hrs