A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood
3 Years
21 Years
Both
Brain and Central Nervous System Tumors
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 Philadelphia | Philadelphia, Pennsylvania 19104 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
