Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	3 to 21 at diagnosis	Pharmaceutical / Industry	CHP-623 BMS-CHP-623, CHP-1999-7-1780, NCI-V01-1677, NCT00031577

Objectives

1. Determine the maximum tolerated dose of paclitaxel when combined with involved-field radiotherapy in children with newly diagnosed, diffuse, intrinsic brain stem glioma.
2. Determine the toxicity of this regimen in these patients.
3. Assess the antitumor activity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and MRI
  • Histologic verification not required
  • Intrinsic (more than 50% intra-axial) involvement of the pons, pons and medulla, pons and midbrain, or entire brain stem allowed
  • Contiguous involvement of the thalamus or upper cervical cord allowed

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No other concurrent anticancer chemotherapy

Endocrine therapy:

• Concurrent corticosteroid therapy for increased intracranial pressure allowed

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent cytochrome P450-inducing anticonvulsants (e.g., phenytoin or carbamazepine) during paclitaxel therapy
• Other concurrent anticonvulsants (e.g., valproic acid) for pre-existing seizure disorder allowed

Patient Characteristics:

Age:

• 3 to 21 at diagnosis

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm3
• Platelet count greater than 100,000/mm3
• Hemoglobin greater than 10.0 g/dL

Hepatic:

• Bilirubin less than 1.5 times normal
• SGOT or SGPT less than 2.5 times normal

Renal:

• Creatinine less than 1.5 times normal

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use a highly effective method of contraception for female patients or barrier contraception for male patients

Expected Enrollment

A minimum of 12 patients will be accrued for this study within 12-18 months.

Outline

This is a multicenter, dose-escalation study of paclitaxel.

Patients receive induction therapy comprising paclitaxel IV over 1 hour once weekly and involved-field radiotherapy (after paclitaxel infusion) once daily, 5 days a week, for 6 weeks.

Beginning 6 weeks after completion of induction therapy, patients may receive maintenance therapy comprising paclitaxel IV over 1 hour once every 3 weeks for a total of 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Children's Hospital of Philadelphia

Jean Belasco, MD, Protocol chair		Ph: 215-590-3129

Registry Information
Official Title		A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood
Trial Start Date		1999-08-04
Registered in ClinicalTrials.gov		NCT00031577
Date Submitted to PDQ		2001-10-10
Information Last Verified		2006-11-28

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