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Home > "T" Clinical Trials Conditions > Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors  Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors
Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors
For Condition: childhood spinal cord tumors,childhood meningioma,childhood brain tumor
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. O6-benzylguanine may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining O6-benzylguanine with temozolomide in treating children who have recurrent or refractory brain tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of temozolomide when administered with O6-benzylguanine (O^6-BG) with and without filgrastim (G-CSF) in pediatric patients with recurrent brain tumors. - Determine the toxic effects of this regimen in these patients. - Determine the pharmacokinetics of temozolomide and O^6-BG in these patients. - Determine the antitumor response of patients treated with temozolomide and O^6-BG. - Correlate MGMT enzyme and mismatch repair protein levels in tumor tissue with outcome in patients treated with this regimen. OUTLINE: This is a dose-escalation study of temozolomide with and without filgrastim (G-CSF). Patients are stratified according to prior radiotherapy (RT)/myeloablative therapy (no RT or focal RT vs craniospinal RT or myeloablative therapy). If neutropenia is the dose-limiting toxicity (DLT) for the first 2 strata, patients are further stratified according to concurrent G-CSF support (yes vs no). Patients receive O6-benzylguanine IV continuously on days 1 and 2 and oral temozolomide on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 2-6 patients in each stratum receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 25% of patients experience DLT. Once the MTD is determined, 12 additional patients are treated at that dose. For courses 1-12, patients experiencing neutropenia may also receive G-CSF subcutaneously or IV daily beginning on day 3 and continuing until blood counts recover. Cohorts of 3-6 patients in each stratum receive escalating doses of temozolomide with G-CSF until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience DLT. Once the MTD is determined, 6 additional patients are treated at that dose. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 72 patients (18 per stratum) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or refractory brain tumor - Histological confirmation waived for brain stem gliomas - Bone marrow involvement by disease allowed PATIENT CHARACTERISTICS: Age - 21 and under Performance status - Karnofsky 60-100% OR - Lansky 60-100% Life expectancy - More than 8 weeks Hematopoietic - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3* - Hemoglobin greater than 8 g/dL* NOTE: *Transfusion independent Hepatic - Bilirubin normal - AST and ALT less than 2.5 times normal - No overt hepatic disease Renal - Creatinine no greater than 1.5 times normal OR - Glomerular filtration rate greater than 70 mL/min - No overt renal disease Cardiovascular - No overt cardiovascular disease Pulmonary - No overt pulmonary disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Neurological deficits allowed provided they have been stable for at least 1 week prior to study - No uncontrolled infection - No hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol - No grade 3 or 4 nonhematopoietic toxicity with prior temozolomide PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from prior biologic therapy - No more than 2 prior biologic therapy regimens - At least 6 months since prior bone marrow transplantation - At least 3 weeks since prior biologic therapy - More than 2 weeks since prior colony-stimulating factor therapy (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) Chemotherapy - Recovered from prior chemotherapy - No more than 2 prior chemotherapy regimens - More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) - More than 3 months since prior temozolomide Endocrine therapy - Concurrent dexamethasone allowed provided dose has been stable for at least 1 week prior to study Radiotherapy - At least 3 months since prior craniospinal radiotherapy (at least 18 Gy) - At least 4 weeks since prior local radiotherapy to the primary tumor - At least 2 weeks since prior focal irradiation to symptomatic metastatic sites Surgery - Not specified Other - No other concurrent anticancer or experimental drugs - Concurrent anticonvulsants allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmarGajjar, Study Chair, St. Jude Children's Research Hospital
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Susan Blaney 832-822-1482
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ian Pollack 412-692-5881
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting James Boyett 901-495-3370
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-9510
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Mark Kieran 617-632-4907
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Henry Friedman 919-684-5301
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting J. Geyer 206-987-6664
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Phillips 215-590-2107
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Roger Packer 202-884-2120
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Stewart Goldman 773-880-4598 ext. 3270
Additional Information:
Study ID Numbers: CDR0000258738; PBTC-005
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052780
Other Childhood Spinal Cord Tumors Studies:
1. Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
2. SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
3. Cilengitide in Treating Children With Refractory Primary Brain Tumors
4. Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
5. Temozolomide in Treating Patients With Progressive Low-Grade Glioma
Related Studies:
Other childhood spinal cord tumors Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors
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