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.
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
- Conditions the study is for
- Brain and Central Nervous System Tumors, Neuroblastoma
- 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
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.
temozolomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2000
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Henry S. Friedman, MD, Study chair, Duke University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy
- ClinicalTrials.gov ID
- NCT00005955
- Acronym / sponsor ID
- 0931
- Keywords
- childhood infratentorial ependymoma, childhood low-grade cerebral astrocytoma, childhood supratentorial ependymoma, childhood craniopharyngioma, localized resectable neuroblastoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2000
- Study completion
- Sep 2002 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temozolomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry S. Friedman, MD study chair
Duke University
1 site in 1 country: see every site and its status.
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.