Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 2 to 18 NCI CCG-0912 CCG-0912

Objectives

I.  Determine the acute and late normal tissue tolerance in the CNS (as 
assessed clinically and radiographically) to a combined regimen of intravenous 
interferon beta and hyperfractionated radiotherapy in children with brainstem 
gliomas.

II.  Determine the toxicity of this regimen.

III.  Assess progression-free survival following this regimen in children with 
brainstem gliomas.

Entry Criteria

Disease Characteristics:

Newly diagnosed, clinically and radiographically (MRI) evident
brainstem glioma that diffusely involves the brainstem,
irrespective of histology, including:

  Tumors that on MRI intrinsically (greater than 50%
  intra-axial) involve the pons, pons and medulla, pons and
  midbrain, or entire brainstem

  Tumors that primarily involve the brainstem but also
  contiguously involve the thalamus or upper cervical cord

Patients with tumors meeting the above criteria are eligible
without histologic confirmation of disease

Tumor that on MRI is localized to the midbrain alone or
cervicomedullary junction alone or has a major portion
(greater than 50%) that exophytically extends dorsally or
laterally out of the brainstem must be anaplastic as
determined by biopsy or partial resection

Entry on study within 4 weeks following surgery or
demonstration of tumor required

No neurofibromatosis allowed

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior cytotoxic chemotherapy allowed

Endocrine therapy:
  Corticosteroids allowed

Radiotherapy:
  No prior radiotherapy allowed

Surgery:
  No more than 4 weeks since any initial surgery

  No postsurgical complications that would indefinitely delay
  therapy

Patient Characteristics:

Age:
  2 to 18 at diagnosis

Performance status:
  Not specified

Life expectancy:
  At least 8 weeks

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No bacterial meningitis that would indefinitely delay
  therapy

  Repeat clinical and neurologic exams and MRI required

Expected Enrollment

20 patients will be entered; if an unacceptable incidence of neurotoxicity or 
skin toxicity is seen, the study will be terminated.

Outline

Nonrandomized study.

Radiotherapy plus Biological Response Modifier Therapy.  Hyperfractionated 
tumor irradiation using megavoltage photon equipment (i.e., Co60 or linear 
accelerators with nominal beam energy of 4-10 MV); plus Interferon beta, 
IFN-B, NSC-373361.

Trial Contact Information

Trial Lead Organizations

Children's Cancer Group

Roger Packer, MD, Protocol chair		Ph: 202-884-2120