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Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma



Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma

For Condition: adult glioblastoma multiforme,recurrent adult brain tumor,adult anaplastic astrocytoma,Mixed Gliomas
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive 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 combining carmustine and O6-benzylguanine in treating patients who have recurrent or progressive glioma.
Details: OBJECTIVES: I. Determine the activity of carmustine and O6-benzylguanine in patients with recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma resistant to nitrosourea. II. Determine the toxic effects of this regimen in these patients. PROTOCOL OUTLINE: Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma; Resistant to nitrosourea (defined as progressive or recurrent disease within 8 weeks of receiving nitrosourea) - Measurable residual disease by MRI or CT scan --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; At least 6 weeks since prior nitrosourea, procarbazine, or mitomycin and recovered; No prior nitrosourea greater than 1,200 mg/m2 - Endocrine therapy: Concurrent stable dose corticosteroids allowed if on for at least two weeks prior to study - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin greater than 10 g/dL - Hepatic: Bilirubin normal; SGOT no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL; BUN no greater than 25 mg/dL - Pulmonary: DLCO greater than 80% predicted - Other: Not pregnant or nursing; Fertile patients must use effective contraception during and for 2 months after study
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
HenryFriedman,  Study Chair,  Duke Comprehensive Cancer Center

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067688;  DUMC-0059-00-1,NCI-T98-0059,DUMC-T98-0059
Study Start Date: August 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005081

Other Adult Anaplastic Astrocytoma Studies:
1. Brachytherapy in Treating Patients With Recurrent Malignant Glioma

2. Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

3. Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma

4. Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma

5. CCI-779 in Treating Patients With Malignant Glioma

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