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Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00720564
First Posted: July 22, 2008
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
City of Hope Medical Center
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors Drug: arsenic trioxide Drug: temozolomide Procedure: adjuvant therapy Radiation: intensity-modulated radiation therapy Radiation: radiation therapy Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Maximum tolerated dose of arsenic trioxide
  • Dose-limiting toxicities as measured by CTCAE version 3.0

Estimated Enrollment: 18
Study Start Date: April 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720564


Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jana Portnow, MD City of Hope Comprehensive Cancer Center
  More Information

Responsible Party: Jana Portnow, City of Hope Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00720564     History of Changes
Other Study ID Numbers: CDR0000600335
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-07058
CEPHALON-CHNMC-07058
First Submitted: July 19, 2008
First Posted: July 22, 2008
Last Update Posted: August 11, 2010
Last Verified: August 2010

Keywords provided by City of Hope Medical Center:
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult gliosarcoma
adult mixed glioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Temozolomide
Dacarbazine
Arsenic trioxide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents