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Home > "I" Clinical Trials Conditions > Imatinib Mesylate With or Without Radiation Therapy in Treating Children With Newly Diagnosed or Recurrent Glioma  Imatinib Mesylate With or Without Radiation Therapy in Treating Children With Newly Diagnosed or Recurrent Glioma
Imatinib Mesylate With or Without Radiation Therapy in Treating Children With Newly Diagnosed or Recurrent Glioma
For Condition: childhood central nervous system germ cell tumor,recurrent childhood brain stem glioma,high-grade childhood cerebral astrocytoma,untreated childhood brain stem glioma,recurrent childhood cerebral astrocytoma
Status: Recruiting
Sponsor(s): Pediatric Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining imatinib mesylate with radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to compare the effectiveness of imatinib mesylate with or without radiation therapy in treating children who have newly diagnosed or recurrentglioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of imatinib mesylate with or without radiotherapy in children with newly diagnosed poor prognosis brainstem glioma or recurrent high-grade intracranial glioma. - Determine the efficacy of these regimens in these patients. - Determine the therapeutic activity of these regimens in these patients. - Determine the pharmacokinetics of these regimens in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to tumor type (newly diagnosed intrinsic brainstem glioma vs recurrent/refractory intracranial high-grade glioma). Patients in stratum II are further stratified according to concurrent enzyme-inducing anticonvulsant use (yes vs no). Patients are assigned to one of two strata. - Stratum I (newly diagnosed brainstem glioma): Patients undergo radiotherapy once daily five days a week for 6 weeks. Beginning 2-3 weeks after completion of radiotherapy, patients without evidence of intratumoral bleed receive oral imatinib mesylate twice daily. Imatinib mesylate treatment repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. - Stratum II (recurrent or refractory high-grade intracranial gliomas): Patients receive imatinib mesylate as in stratum I. Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 5 of 6 patients experience no dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 60 patients (30 per stratum) 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: - Stratum I: - Newly diagnosed diffuse intrinsic brainstem malignant glioma - No disseminated disease - No radiographic evidence of intratumoral hemorrhage - Stratum II: - Histologically confirmed recurrent or refractory anaplastic astrocytoma, glioblastoma multiforme, or other high-grade glioma (including recurrent brain stem glioma - No intratumoral hemorrhage unrelated to prior surgical procedure PATIENT CHARACTERISTICS: Age: - 3 to 21 Performance status: - Karnofsky 50-100% OR - Lansky 50-100% Life expectancy: - More than 8 weeks Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3 (transfusion independent) - Hemoglobin greater than 8 g/dL (transfusion allowed) Hepatic: - Bilirubin no greater than 1.5 times normal for age - SGPT less than 3 times normal for age - Albumin at least 2 g/dL - No significant hepatic disease Renal: - Creatinine less than 1.5 times normal for age OR - Glomerular filtration rate greater than 70 mL/min - No significant renal disease Cardiovascular: - No significant cardiac disease - No deep venous or arterial thrombosis within the past 6 weeks Pulmonary: - No significant pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 6 months after study participation - No uncontrolled infection - No significant gastrointestinal disease - No significant psychiatric disease - Neurological deficits allowed if stable for at least 1 week prior to study (stratum II) PRIOR CONCURRENT THERAPY: Biologic therapy: - More than 2 weeks since prior colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) - At least 3 months since prior bone marrow transplantation (stratum II) Chemotherapy: - No prior chemotherapy (stratum I) - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered (stratum II) Endocrine therapy: - Prior routine corticosteroids allowed - Concurrent corticosteroids allowed if on stable or decreasing dose for at least 1 week prior to study Radiotherapy: - Stratum I: - No prior radiotherapy - Stratum II: - At least 3 months since prior craniospinal radiotherapy (18 Gy or more) - At least 8 weeks since prior local radiotherapy to primary tumor - At least 2 weeks since prior focal radiotherapy for symptomatic metastases Surgery: - See Disease Characteristics Other: - No prior imatinib mesylate (stratum II) - At least 2 weeks since beginning or discontinuing medications affecting cytochrome P450 3A4, 5, and 7 isoenzyme metabolism - No other concurrent anticancer drug - No other concurrent experimental drug - No concurrent warfarin - No concurrent enzyme-inducing anticonvulsant drugs (stratum I)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanPollack, Study Chair, Children's Hospital of Pittsburgh
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-9510
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Stewart Goldman 773-880-4598 ext. 3270
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
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
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Susan Blaney 832-822-1482
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 Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Tina Poussaint 617-355-6450
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Phillips 215-590-2107
Additional Information:
Study ID Numbers: CDR0000068761; PBTC-006
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021229
Other Recurrent Childhood Brain Stem Glioma Studies:
1. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
2. Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
3. Chemotherapy, Surgery, Radiation Therapy and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Primary CNS Germ Cell Tumors
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer
5. Imatinib Mesylate With or Without Radiation Therapy in Treating Children With Newly Diagnosed or Recurrent Glioma
Related Studies:
Other recurrent childhood brain stem glioma Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Imatinib Mesylate With or Without Radiation Therapy in Treating Children With Newly Diagnosed or Recurrent Glioma
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