Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma - Full Text View

Sponsored by:	Children's Hospital of Philadelphia
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00031577

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: paclitaxel Procedure: radiation therapy	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	12
Study Start Date:	August 1999

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 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

Ages Eligible for Study:	3 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031577

Locations

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

Investigators

Study Chair:

Jean B. Belasco, MD

Children's Hospital of Philadelphia

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000069064, CHP-623, BMS-CHP-623, CHP-1999-7-1780, NCI-V01-1677
Study First Received:	March 8, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00031577
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated childhood brain stem glioma

Study placed in the following topic categories:

Neuroectodermal Tumors
Paclitaxel
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Mitosis Modulators
Antimitotic Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009