A Phase II Trial of Paclitaxel and Topotecan With Filgrastim in Patients With Recurrent or Refractory Glioblastoma Multiforme or Anaplastic Astrocytoma
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase II Trial of Paclitaxel and Topotecan With Filgrastim in Patients With Recurrent or Refractory Glioblastoma Multiforme or Anaplastic Astrocytoma
OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent
glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and
topotecan (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine
survival in these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor
p53 expression in relation to response to TAX/TOPO/G-CSF.
OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2
courses and until 2 courses beyond maximum response. Patients are followed every 3 months
for 2 years, then every 6 months for relapse and survival.
PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the
first 20 patients.
Inclusion Criteria
DISEASE CHARACTERISTICS: Biopsy proven glioblastoma multiforme or anaplastic astrocytoma
Central pathologic review at Dartmouth-Hitchcock Medical Center, including assay for tumor
p53 expression No anaplastic oligodendroglioma No mixed oligodendroastrocytoma Recurrent
or progressive disease following radiotherapy documented by CT or MRI within 2 weeks of
entry
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%
Hematopoietic: WBC at least 3,000 ANC at least 1,500 Platelets at least 100,000 Hepatic:
Bilirubin no greater than 1.0 mg/dL AST/ALT no greater than 2.5 times normal Renal:
Creatinine no greater than 1.5 mg/dL Other: No documented sensitivity to E. coli-derived
products No major medical or psychiatric illness that would interfere with therapy or
compliance with scheduled follow-up No pregnant or nursing women Adequate contraception
required of fertile patients
PRIOR CONCURRENT THERAPY: No prior taxanes or topoisomerase I inhibitors At least 4 weeks
since chemotherapy (6 weeks since nitrosoureas) At least 4 weeks since radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Camilo E Fadul, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dartmouth-Hitchcock Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
D9607
NCT ID:
NCT00002814
Start Date:
August 1996
Completion Date:
December 2001
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult glioblastoma
- adult anaplastic astrocytoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Astrocytoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
