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Home > "C" Clinical Trials Conditions > Carmustine Implants and O(6)-Benzylguanine in Treating Children With Recurrent Malignant Glioma  Carmustine Implants and O(6)-Benzylguanine in Treating Children With Recurrent Malignant Glioma
Carmustine Implants and O(6)-Benzylguanine in Treating Children With Recurrent Malignant Glioma
For Condition: recurrent childhood cerebral astrocytoma
Status: Recruiting
Sponsor(s): Pediatric Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy placed into the surrounding tissue after surgery to remove the tumor may kill any remaining tumor cells. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining O(6)-benzylguanine with carmustine implants in treating children who have recurrentmalignantglioma.
Details: OBJECTIVES: - Determine the dose of O(6)-benzylguanine that reliably inhibits alkylguanine-DNA alkyltransferase activity in pediatric patients with recurrent malignant glioma. - Determine the toxic effects of O(6)-benzylguanine and polifeprosan 20 with carmustine implant (Gliadel) in these patients. - Determine antitumor response in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of O(6)-benzylguanine. Patients receive O(6)-benzylguanine (O6-BG) IV over 1 hour immediately followed by O6-BG IV continuously for 9 days. Two days after initiation of continuous infusion of O6-BG, patients undergo maximal tumor debulking. At the time of surgery, patients receive up to 8 polifeprosan 20 wafers with carmustine (Gliadel) implanted into the resection cavity. Cohorts of up to 14 patients receive escalating doses of continuous infusion O6-BG until the optimally biologically effective dose (BED) is determined. The BED is defined as the dose at which at least 11 of 14 patients meet the target of complete suppression of alkylguanine-DNA alkyltransferase levels. Patients are followed at day 11, at weeks 2, 4, 6, 8, and 12, at months 6, 9, and 12, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed progressive supratentorial anaplastic astrocytoma or glioblastoma multiforme - No multifocal disease or leptomeningeal dissemination of tumor - No evidence of tumor crossing midline - Limited intraventricular involvement - Measurable unilateral mass at least 10 mm by contrast-enhanced MRI - Received prior involved-field radiotherapy as a component of prior therapy - Amenable to and in need of significant debulking PATIENT CHARACTERISTICS: Age - 3 to 21 Performance status - Karnofsky 60-100% OR - Lansky 60-100% Life expectancy - More than 8 weeks Hematopoietic - Absolute neutrophil count greater than 1,000/mm3* - Platelet count greater than 100,000/mm3* - Hemoglobin greater than 8 g/dL (transfusions allowed) NOTE: * Transfusion independent Hepatic - Bilirubin no greater than 1.5 times normal - AST and ALT less than 3 times normal - Albumin at least 2 g/dL - No overt hepatic disease Renal - Creatinine clearance no greater than 1.5 times normal OR - Glomerular filtration rate greater than 70 mL/min - No overt renal disease Cardiovascular - No overt cardiac disease Pulmonary - No overt pulmonary disease Other - Neurological deficits must be stable for at least the past week - No uncontrolled infection - No known hypersensitivity to nitrosoureas or polyethylene glycol - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 6 months since prior bone marrow transplantation - More than 2 weeks since prior colony-stimulating growth factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) Chemotherapy - No more than 2 prior cytotoxic chemotherapy regimens - No more than 3 prior chemotherapy regimens total - More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered - Prior systemic carmustine (or other nitrosourea) allowed provided patient did not experience non-hematopoietic grade III/IV toxicity Endocrine therapy - Concurrent dexamethasone allowed if on a stable dose for at least the past week Radiotherapy - See Disease Characteristics - At least 3 months since prior radiotherapy - No prior craniospinal irradiation for metastatic disease Surgery - See Disease Characteristics - Prior biopsy or cytoreductive surgery allowed Other - Concurrent anticonvulsants allowed - No other concurrent anticancer or investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanPollack, Study Chair, Children's Hospital of Pittsburgh
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Henry Friedman 919-684-5301
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ian Pollack 412-692-5881
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Roger Packer 202-884-2120
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting J. Geyer 206-987-6664
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94143-0372
United States
Recruiting Michael Prados 415-353-2966
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Phillips 215-590-2107
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Susan Blaney 832-822-1482
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Mark Kieran 617-632-4907
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting James Boyett 901-495-3370
Additional Information:
Study ID Numbers: CDR0000257268; PBTC-009
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045721
Other Recurrent Childhood Cerebral Astrocytoma Studies:
1. High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas
2. Docetaxel in Treating Children With Recurrent Solid Tumors
3. Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma
4. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
5. Combination Chemotherapy in Treating Children With Progressive Brain Tumors
Related Studies:
Other recurrent childhood cerebral astrocytoma Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Carmustine Implants and O(6)-Benzylguanine in Treating Children With Recurrent Malignant Glioma
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