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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00031577
• Other study ID #: 1999-6-1780
• Secondary ID: CHP-623BMS-CHP-6
• Status: Terminated
• Phase: Phase 1
• First received: March 8, 2002
• Last updated: March 17, 2015
• Start date: August 1999
• Est. completion date: September 2006

Study information

• Verified date: January 2014
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• paclitaxel

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Egleston	Georgia
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States,