Brain Tumor |
Brain Cancer; Brain Cancer (Brain Tumor); Brain Tumors; Cancer, Brain |
Clinical Trial: Combination Chemotherapy for Patients With Brain Cancer
This study is no longer recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult glioblastoma multiforme adult anaplastic astrocytoma recurrent adult brain tumor | Drug: filgrastim Drug: paclitaxel Drug: topotecan | Phase II |
MedlinePlus related topics: Brain Cancer; Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Paclitaxel/Topotecan/G-CSF for Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma
Study start: August 1996
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.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY 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
--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
--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
Location Information
Camilo E. Fadul, Study Chair, Norris Cotton Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002814
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Adult Brain Tumors (PDQ®): Treatment (National Cancer Institute)
- Adult Brain TumorTreatment - Patients (National Cancer Institute)

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