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


Phase 1
3 Years
21 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jean B. Belasco, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Philadelphia

Authority:

United States: Federal Government

Study ID:

CDR0000069064

NCT ID:

NCT00031577

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood brain stem glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322