Clinical trial · Interventional

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

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

NCT00005955CI-TRIAL-00010879completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
temozolomide	Drug	Temozolomide	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 4 Years
Maximum age: 21 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Aug 1, 2000
Primary completion: —
Completion: Sep 1, 2002
First posted: Jan 27, 2003
Last update posted: Jun 20, 2013
Lead sponsor: Duke University OTHER
Collaborators: National Cancer Institute (NCI)
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, childhood central nervous system embryonal tumor, childhood central nervous system mixed germ cell tumor, childhood central nervous system teratoma, childhood central nervous system yolk sac tumor

Data updated 22 days agoSource updated Jun 20, 2013source: clinicaltrials

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