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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031577
Recruitment Status : Terminated (Administrative closure 9/22/2006. Decline in enrollment at CHOP. due to competing protocols with new agents.)
First Posted : January 27, 2003
Last Update Posted : March 19, 2015
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: paclitaxel Radiation: radiation therapy Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Primary Purpose: Treatment
Official Title: A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood
Study Start Date : August 1999
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 3 to 21 at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified


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


  • Bilirubin less than 1.5 times normal
  • serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 2.5 times normal


  • Creatinine less than 1.5 times normal


  • 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


Biologic therapy:

  • Not specified


  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • Concurrent corticosteroid therapy for increased intracranial pressure allowed


  • Not specified


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00031577

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United States, Georgia
Winship Cancer Institute of Emory University
Egleston, Georgia, United States, 30322
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
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Study Chair: Jean B. Belasco, MD Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT00031577    
Other Study ID Numbers: 1999-6-1780
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: January 2014
Keywords provided by Children's Hospital of Philadelphia:
untreated childhood brain stem glioma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action