search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
radiation therapy
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring untreated childhood brain stem glioma

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Winship Cancer Institute of Emory University
  • Children's Hospital of Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
March 17, 2015
Sponsor
Children's Hospital of Philadelphia
search

1. Study Identification

Unique Protocol Identification Number
NCT00031577
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Administrative closure 9/22/2006. Decline in enrollment at CHOP. due to competing protocols with new agents.
Study Start Date
August 1999 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
untreated childhood brain stem glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean B. Belasco, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
Facility Information:
Facility Name
Winship Cancer Institute of Emory University
City
Egleston
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs