Expired Study
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Duarte, California 91010


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000600335


NCT ID:

NCT00720564


Secondary ID:

P30CA033572


Study Acronym:


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)


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

City of Hope Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jana Portnow, MD
Principal Investigator
Beckman Research Institute

Study Dates

Start Date:April 2008
Completion Date:February 2009
Completion Type:Actual
Primary Completion Date:February 2009
Primary Completion Type:Actual
Verification Date:August 2010
Last Changed Date:August 9, 2010
First Received Date:July 19, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Dose-limiting toxicities as measured by CTCAE version 3.0
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Maximum tolerated dose of arsenic trioxide
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:arsenic trioxide
Intervention Type:Drug
Name:temozolomide
Intervention Type:Procedure
Name:adjuvant therapy
Intervention Type:Radiation
Name:intensity-modulated radiation therapy
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:City of Hope Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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