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Brain and Central Nervous System TumorsPhase 2NCT00003466

Temozolomide in Treating Patients With Progressive Low-Grade Glioma

A Phase 2 study testing temozolomide in people with Brain and Central Nervous System Tumors, run by Duke University at 2 sites 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma. Read more about this study

Who is it for?
Ages 4 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
temozolomide
How many people
100 participants
Where
2 sitesUnited States
Study dates
Mar 1998to Jul 2005
Phase
Phase 2
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 4 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:
  • Astrocytoma
  • Oligodendroglioma
  • Mixed glioma
  • Optic pathway glioma*
  • Pontine glioma* NOTE: *Biopsy not required
  • Patients with optic pathway glioma must also meet the following criteria:
  • Progressive loss of vision as defined by doubling of octaves
  • Visual acuity loss not explained by other causes
  • Increase in proptosis of greater than 3 mm
  • Increase in diameter of optic nerve of at least 2 mm on neuroimaging
  • Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

  • 4 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2 times ULN

Renal:

  • Creatinine less than 1.5 times ULN
  • BUN less than 1.5 times ULN

Other:

  • Must be neurologically stable
  • No systemic disease
  • No acute infection requiring IV antibiotics
  • No frequent vomiting
  • No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)
  • No other prior or concurrent malignancies except:
  • Surgically cured carcinoma in situ of the cervix
  • Basal or squamous cell skin cancer
  • HIV negative
  • No AIDS-related illness
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy (growth factors or epoetin alfa)

Chemotherapy:

  • At least 6 weeks since prior chemotherapy unless evidence of disease progression
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 6 weeks since prior radiotherapy unless evidence of disease progression
  • No concurrent radiotherapy

Surgery:

  • At least 3 weeks since prior surgery unless evidence of disease progression
  • Recovered from all prior surgery

Other:

  • No other concurrent investigational drugs

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318

Other trials in United States

About this study

Official title: Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.

Read the detailed description

OBJECTIVES:

  • Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.
  • Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.

OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).

Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.

Being tested
temozolomide
Keywords
recurrent adult brain tumor, adult mixed glioma, childhood mixed glioma, adult pilocytic astrocytoma, adult subependymoma, recurrent childhood cerebral astrocytoma, adult brain stem glioma, recurrent childhood brain stem glioma, untreated childhood brain stem glioma, recurrent childhood visual pathway and hypothalamic glioma, untreated childhood visual pathway and hypothalamic glioma, adult oligodendroglioma, adult diffuse astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioma, Astrocytoma, Glioma, Subependymal, Optic Nerve Glioma, Oligodendroglioma

What participants receive

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

What is being measured

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

  1. Response rate

  2. Activity of temozolomide

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 1998
  3. Primary completionJul 2005
  4. Study completionJul 2005

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 2
Primary purpose
Treatment
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003466
Sponsor's protocol ID
1703 (CDR0000066502)
Other IDs
DUMC-1703-04-12R7, DUMC-000693-01-3R1, DUMC-1703-01-94R, DUMC-1502-97-10, DUMC-1569-98-10R1, DUMC-97125, NCI-G98-1469, DUMC-1703-02-9R5
Status last verified
Feb 2013
First submitted
1 Nov 1999
Last updated
9 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temozolomide in people with Brain and Central Nervous System Tumors, run by Duke University at 2 sites 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 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Response rate. 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 NCT00003466.

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 9 Jul 2014.

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