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Home > "O" Clinical Trials Conditions > O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma  O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
For Condition: adult brain stem glioma,adult glioblastoma multiforme,Mixed Gliomas,adult ependymoma,adult anaplastic astrocytoma,recurrent adult brain tumor,Adult Oligodendroglioma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Johns Hopkins Oncology 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 and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of O6-benzylguanine and implanted carmustine wafers in treating patients who have recurrent malignant glioma.
Details: OBJECTIVES: I. Determine the dose of O6-benzylguanine that completely suppresses AGT levels in patients with recurrent malignant glioma. II. Evaluate the safety and tolerance of increasing duration for up to 2 weeks of continuously infused O6-benzylguanine at a dose that will completely suppress tumor AGT activity combined with intracranially implanted polifeprosan 20 with carmustine implants (Gliadel wafers) in this patient population. PROTOCOL OUTLINE: This is a dose escalation study of O6-benzylguanine (O6-BG). Patients in the first cohort receive O6-BG IV over 1 hour followed by continuous infusion of O6-BG for 2 days prior to surgery. Patients undergo surgical resection and receive up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) in the resected tumor cavity. Cohorts of 14 patients receive escalating doses of O6-BG until 11 out of 14 patients in a cohort have complete suppression of AGT levels. Once the dose of O6-BG that completely suppresses AGT has been established, subsequent patients receive O6-BG IV beginning at least 1 hour prior to surgery followed by the established continuous infusion dose beginning on the day of surgery. The infusion continues for up to 14 days postoperatively. Cohorts of 6-12 patients receive lengthened durations of continuous infusion O6-BG until the maximum tolerated dose (MTD) is determined or the length of the infusion reaches 14 days. The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose limiting toxicities. Patients are followed at 3, 6, 9, and 12 months, and then until death. PROJECTED ACCRUAL: A minimum of 38 patients will be accrued for this study over 9.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignant glioma determined from prior stereotactic biopsy or cytoreductive surgery for removal of a supratentorial brain tumor; Unilateral supratentorial tumor, measuring at least 1 cm, as determined by CT scan or MRI; No more than 1 focus of tumor and no tumor crossing the midline - Surgical treatment indicated at baseline evaluation - Received prior definitive (greater than 5,000 cGy) external beam radiotherapy more than 3 months ago - Evidence of progression - At time of tumor resection and Gliadel wafers implantation: Intraoperative pathological diagnosis on frozen section or squash preparation of malignant glioma OR Glioblastoma multiforme or anaplastic astrocytoma on permanent sections from a prior surgery and an intraoperative pathological diagnosis on frozen section or squash preparation of tumor, glioma, or malignant glioma (not necrosis) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered; No other concurrent chemotherapy during first 56 days of study - Endocrine therapy: No concurrent dexamethasone as an antiemetic - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: At least 60 days - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 4 times upper limit of normal - Renal: Creatinine no greater than 1.7 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception for 1 year after surgery; No other concurrent significant life threatening disease; No known hypersensitivity to nitrosoureas; No other malignancy in past five years except curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonWeingart, Study Chair, Johns Hopkins Oncology Center
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Additional Information:
Study ID Numbers: CDR0000067569; JHOC-NABTT-9803,NABTT-9803
Study Start Date: November 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004892
Other Adult Brain Stem Glioma Studies:
1. O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
2. Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma
3. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
4. Antineoplaston Therapy in Treating Patients With Ependymoma
Related Studies:
Other adult brain stem glioma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
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