Clinical trial NCT00031577: Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Official title: A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Brain and Central Nervous System Tumors
Keywords: untreated childhood brain stem glioma
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 11
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 intravenously (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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and magnetic resonance imaging (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
* serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Egleston
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jean B. Belasco, MD
role: STUDY_CHAIR
References: