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A Phase II Trial of Paclitaxel and Topotecan With Filgrastim in Patients With Recurrent or Refractory Glioblastoma Multiforme or Anaplastic Astrocytoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

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 CenterLebanon, New Hampshire  03756