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. Paclitaxel may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma.

Condition	Treatment or Intervention	Phase
untreated childhood brain stem glioma	Drug: paclitaxel  Procedure: chemotherapy  Procedure: radiation therapy  Procedure: radiosensitization	Phase I

Further Study Details: 

OBJECTIVES:

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

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.

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

Ages Eligible for Study:  3 Years   -   21 Years,  Genders Eligible for Study:  Both

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

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

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

Georgia
      Winship Cancer Institute of Emory University, Egleston,  Georgia,  30322,  United States; Recruiting
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

Study chairs or principal investigators

Jean Bello Belasco, MD,  Study Chair,  Children's Hospital of Philadelphia   

Study ID Numbers:  CDR0000069064; CHP-623; BMS-CHP-623; CHP-1999-7-1780; NCI-V01-1677; NCT00031577
Record last reviewed:  December 2004
Last Updated:  January 6, 2005
Record first received:  March 8, 2002
ClinicalTrials.gov Identifier:  NCT00031577
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08