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Brain and Central Nervous System TumorsPhase 1NCT00720564

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

A Phase 1 study testing arsenic trioxide, temozolomide and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
arsenic trioxide, temozolomide and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
18 participants
Where
1 siteUnited States
Study dates
Apr 2008to Feb 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
arsenic trioxide, temozolomide, adjuvant therapy, intensity-modulated radiation therapy, radiation therapy
Keywords
adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult gliosarcoma, adult mixed glioma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Gliosarcoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arsenic trioxideDrug

  • temozolomideDrug

  • adjuvant therapyProcedure or surgery

  • intensity-modulated radiation therapyRadiation

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of arsenic trioxide

  2. Dose-limiting toxicities as measured by CTCAE version 3.0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720564
Sponsor's protocol ID
CDR0000600335
Other IDs
P30CA033572, CHNMC-07058, CEPHALON-CHNMC-07058
Status last verified
Aug 2010
First submitted
19 Jul 2008
Last updated
11 Aug 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing arsenic trioxide, temozolomide and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of arsenic trioxide. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00720564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2010; AzTrials last refreshed its copy on 7 Nov 2026.

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