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Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
This study is ongoing, but not recruiting participants.
Study NCT00031577   Information provided by National Cancer Institute (NCI)
First Received: March 8, 2002   Last Updated: February 6, 2009   History of Changes

March 8, 2002
February 6, 2009
August 1999
 
 
 
Complete list of historical versions of study NCT00031577 on ClinicalTrials.gov Archive Site
 
 
 
Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood

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.

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.

Phase I
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: paclitaxel
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
12
 
 

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
Both
3 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00031577
 
CDR0000069064, CHP-623, BMS-CHP-623, CHP-1999-7-1780, NCI-V01-1677
Children's Hospital of Philadelphia
 
Study Chair: Jean B. Belasco, MD Children's Hospital of Philadelphia
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP