Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors - Full Text View

Sponsor:	Duke University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00005955

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Neuroblastoma	Drug: temozolomide	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma

MedlinePlus related topics: Cancer Neuroblastoma

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by Duke University:

Study Start Date:	August 2000
Study Completion Date:	September 2002

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.

Eligibility

Ages Eligible for Study:	4 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005955

Locations

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators

Study Chair:

Henry S. Friedman, MD

Duke University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Henry Friedman, MD, Duke UMC
ClinicalTrials.gov Identifier:	NCT00005955 History of Changes
Other Study ID Numbers:	CDR0000067936, DUMC-0931-02-6R3, DUMC-000931-00-5R1, DUMC-0831-99-5, NCI-G00-1799, DUMC-000931-01-6R1
Study First Received:	July 5, 2000
Last Updated:	October 12, 2009
Health Authority:	United States: Federal Government

Keywords provided by Duke University:

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

Additional relevant MeSH terms:

Nervous System Neoplasms
Neuroblastoma
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012