Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma - Full Text View

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028795

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. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy Surgery

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Improved outcome [ Designated as safety issue: No ]
Toxicity as assessed by NCI CTCAE v. 2.0 [ Designated as safety issue: Yes ]

Study Start Date:

December 2002

Detailed Description:

OBJECTIVES:

Compare the event-free survival of patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma (DIPG) treated with adjuvant temozolomide administered concurrently with postoperative radiotherapy and then alone as maintenance therapy vs historical control cohorts treated in prior Pediatric Oncology Group and Children's Cancer Group studies.
Determine the toxicity of this regimen in these patients.
Determine the efficacy of this regimen in patients with DIPG.
Determine the toxicity of this regimen in patients with DIPG.

OUTLINE: This is a multicenter study.

Adjuvant chemoradiotherapy: Beginning within 6 weeks after surgical resection or diagnosis*, patients without gross residual disease undergo cranial irradiation 5 days a week for 6 weeks. Beginning within 6 weeks after surgical resection, patients with gross residual disease undergo radiotherapy as above followed by boost radiotherapy for 1 week. All patients receive oral temozolomide once daily beginning within 5 days after initiation of radiotherapy and continuing for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
Adjuvant maintenance therapy: Beginning 4 weeks after completion of adjuvant chemoradiotherapy, patients receive oral temozolomide on days 1-5.

Treatment repeats every 28 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *For patients with diffuse intrinsic pontine glioma only

Patients are followed every 3-6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months.

Eligibility

Ages Eligible for Study:	3 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed newly diagnosed CNS tumor of the following types:
- High grade glioma (HGG) of one of the following histologies:
  - Anaplastic astrocytoma (grade III)
  - Glioblastoma multiforme (grade IV)
  - Gliosarcoma
  - Primary spinal cord malignant glioma
- Diffuse intrinsic pontine glioma (DIPG)
  - Diagnosed by gadolinium-enhanced MRI
  - At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons
  - No diffuse leptomeningeal disease
  - No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:
    - Dorsally exophytic brainstem glioma
    - Cervico-medullary junction tumor
    - Focal low-grade glioma of the midbrain or brainstem
  - No diffuse brainstem enlargement due to neurofibromatosis
No primary brain stem malignant glioma
No M+ disease (CSF positive for tumor or metastatic disease)
Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients)

PATIENT CHARACTERISTICS:

Age:

3 to 21

Performance status:

Karnofsky 50-100% OR
Lansky 50-100%

Life expectancy:

At least 2 months

Hematopoietic:

Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 100,000/mm^3*
Hemoglobin at least 10.0 g/dL* NOTE: *Transfusion independent

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT or SGPT less than 2.5 times ULN

Renal:

Creatinine no greater than 1.5 times ULN

Other:

No other concurrent malignancy
Concurrent seizure disorder allowed if well controlled on anticonvulsants
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

Biologic:

No concurrent routine cytokine support

Chemotherapy:

Not specified

Endocrine therapy:

No concurrent corticosteroids except for increased intracranial pressure in patients with CNS tumors

Radiotherapy:

See Disease Characteristics

Surgery:

See Disease Characteristics

Other:

No prior therapy for HGG or DIPG

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028795

Show 230 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Kenneth J. Cohen, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

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

Publications:

Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50.

Study ID Numbers:	CDR0000069135, COG-ACNS0126
Study First Received:	January 4, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00028795 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

childhood brain stem glioma
childhood high-grade cerebral astrocytoma
childhood spinal cord neoplasm
untreated childhood brain stem glioma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Spinal Cord Neoplasm
Adjuvants, Immunologic
Central Nervous System Neoplasms
Temozolomide
Neuroectodermal Tumors
Brain Stem Glioma, Childhood
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Spinal Cord Neoplasms
Antineoplastic Agents, Alkylating
Glioma
Glioblastoma Multiforme
Gliosarcoma
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Neoplasms
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Glioma
Neoplasms, Neuroepithelial
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009