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Home > "C" Clinical Trials Conditions > Combination Chemotherapy for Patients With Brain Cancer  Combination Chemotherapy for Patients With Brain Cancer
Combination Chemotherapy for Patients With Brain Cancer
For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma,recurrent adult brain tumor
Status: No longer recruiting
Sponsor(s): Norris Cotton Cancer Center ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CamiloFadul, Study Chair, Norris Cotton Cancer Center
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Additional Information:
Study ID Numbers: CDR0000064961; DMS-9607,NCI-V96-0955
Study Start Date: August 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002814
Other Recurrent Adult Brain Tumor Studies:
1. Talampanel and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
2. Irinotecan in Treating Patients With Recurrent Malignant Glioma
3. High-Dose Methotrexate and Leucovorin Followed By Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
4. Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
5. Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other New Hampshire Clinical Trials
Other Lebanon Clinical Trials
Combination Chemotherapy for Patients With Brain Cancer
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