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Brain and Central Nervous System TumorsPhase 2NCT00005955

Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors

A Phase 2 study testing temozolomide in people with Brain and Central Nervous System Tumors and Neuroblastoma, run by Duke University 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy combined with radiation therapy may kill more tumor cells. Read more about this study

Who is it for?
Ages 4 to 21 years
What is being tested?
temozolomide
How many people
Not given
Where
1 siteUnited States
Study dates
Aug 2000to Sep 2002
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 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed malignant central nervous system tumor not requiring immediate radiotherapy
  • Patients with diffuse pontine tumors do not require histological confirmation
  • Eligible types include the following:
  • Ependymoma
  • Malignant glioma
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Anaplastic oligodendroglioma
  • Gliosarcoma
  • Anaplastic mixed oligoastrocytoma
  • Brainstem glioma
  • Primitive neuroectodermal tumor
  • Nongerminoma germ cell tumor
  • At least one bidimensionally measurable lesion
  • At least 1.5 cm2 within 72 hours of surgical resection or greater than 14 days after surgery
  • Diffuse pontine tumors are not required to be measurable
  • Neurologically stable

PATIENT CHARACTERISTICS:

Age:

  • 4 to 21

Performance status:

  • Karnofsky or Lansky 70-100%

Life expectancy:

  • Greater 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)
  • Alkaline phosphatase less than 2 times ULN
  • SGOT and SGPT less than 2.5 times ULN

Renal:

  • BUN and creatinine less than 1.5 times ULN

Other:

  • Must be able to swallow capsules
  • No acute infection treated with intravenous antibiotics
  • No nonmalignant systemic disease that makes patient a poor medical risk
  • No frequent vomiting or medical condition that may interfere with oral medication intake (e.g., partial bowel obstruction)
  • No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No more than one prior biologic therapy regimen
  • No concurrent biologic therapy
  • No concurrent growth factors or epoetin alfa

Chemotherapy:

  • No more than one prior chemotherapy regimen
  • No other concurrent chemotherapy

Endocrine therapy:

  • No increasing doses of steroids within one week of study

Radiotherapy:

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery:

  • At least 2 weeks, but no greater than 4 weeks, since prior surgical resection and recovered

Other:

  • No other concurrent investigational drugs

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy combined with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors.

Read the detailed description

OBJECTIVES:

  • Determine the response rate to treatment with temozolomide in children with newly diagnosed malignant central nervous system tumors.
  • Determine the toxicity of this treatment in these patients.
  • Determine the overall survival in these patients for 18 months following the study after receiving this treatment.

OUTLINE: Patients are stratified according to type of disease (ependymoma vs brain stem glioma vs malignant glioma vs other).

Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial or complete response may receive an additional 8 courses of temozolomide following radiotherapy.

PROJECTED ACCRUAL: A maximum of 100 patients (25 per stratum) will be accrued for this study over 24-36 months.

Being tested
temozolomide
Keywords
childhood infratentorial ependymoma, childhood low-grade cerebral astrocytoma, childhood supratentorial ependymoma, childhood craniopharyngioma, localized resectable neuroblastoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood cerebellar astrocytoma, untreated childhood medulloblastoma, untreated childhood visual pathway and hypothalamic glioma, newly diagnosed childhood ependymoma, childhood central nervous system choriocarcinoma
Medical subject headings
Central Nervous System Neoplasms, Neuroblastoma, Astrocytoma, Oligodendroglioma, Choroid Plexus Neoplasms

What participants receive

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

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 startAug 2000
  3. Study completionSep 2002

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005955
Sponsor's protocol ID
0931
Other IDs
DUMC-0931-02-6R3, DUMC-000931-00-5R1, DUMC-0831-99-5, NCI-G00-1799, DUMC-000931-01-6R1, CDR0000067936
Status last verified
Oct 2009
First submitted
5 Jul 2000
Last updated
20 Jun 2013
Results posted
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 and Neuroblastoma, run by Duke University 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 20 Jun 2013. 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 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.

Where can I read the original study information?
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 20 Jun 2013.

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