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Home > "T" Clinical Trials Conditions > Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma  Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
For Condition: untreated childhood brain stem glioma
Status: Recruiting
Sponsor(s): Pediatric Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining tipifarnib with radiation therapy in treating young patients who have newly diagnosed brain stem glioma.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of tipifarnib and radiotherapy in patients with non-disseminated, diffuse, intrinsic brainstem gliomas. - Determine the efficacy of this regimen in these patients. Secondary - Determine the toxic effects of this regimen in these patients. - Determine the radiographic changes of brainstem gliomas using MRI, magnetic resonance spectroscopy, perfusion and diffusion imaging, and positron-emission tomography scans in patients treated with this regimen. OUTLINE: This is a phase I, multicenter, dose-escalation study of tipifarnib followed by a phase II safety and efficacy study. - Patients undergo radiotherapy 5 days a week for 6 weeks. Beginning 1 or 2 days before radiotherapy, patients receive oral tipifarnib twice daily until the completion of radiotherapy. Beginning 2 weeks after the completion of radiotherapy, patients receive oral tipifarnib twice daily on weeks 1-3. Treatment repeats every 4 weeks for up to 11 additional courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tipifarnib during radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients undergo radiotherapy and receive tipifarnib at the MTD as in phase I. Treatment continues for up to 24 months (26 courses) in the absence of disease progression or unacceptable toxicity. Patients are followed for up to 1 year. PROJECTED ACCRUAL: A total of 3-46 patients (3-12 patients for phase I and a total of 40 patients for phase II [including 6 patients treated in the dose-finding portion of phase I]) will be accrued for this study within 2.3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-disseminated, intrinsic diffuse brainstem glioma - Newly diagnosed disease - No disseminated disease PATIENT CHARACTERISTICS: Age - 3 to 21 Performance status - Karnofsky 50-100% (patients 17 to 21 years of age) OR - Lansky 50-100% (patients 3 to 16 years of age) Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,000/mm^3 - Platelet count 100,000/mm^3* - Hemoglobin 8 g/dL* NOTE: *Transfusion independent Hepatic - ALT and AST < 2.5 times upper limit of normal (ULN) - Bilirubin 1.5 ULN Renal - Creatinine < ULN OR - Glomerular filtration rate > 70 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study participation - No progressive neurological deficits for at least the past week - No other significant medical illness that would preclude study participation - No uncontrolled infection - No disease that would obscure toxicity or dangerously alter drug metabolism PRIOR CONCURRENT THERAPY: Biologic therapy - More than 2 weeks since prior filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa - No prior bone marrow transplantation Chemotherapy - No prior chemotherapy Endocrine therapy - Concurrent corticosteroids allowed if on a stable or decreasing dose for at least the past week Radiotherapy - No prior radiotherapy Surgery - Not specified Other - No concurrent enzyme-inducing anticonvulsant drugs (EIACD) - Patients switched from EIACD to non-EIACD for at least 7 days before study participation allowed - No other concurrent anticancer therapy - No other concurrent experimental drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DaphneHaas-Kogan, Study Chair, University of California, San Francisco
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Phillips 215-590-2107
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Henry Friedman 919-684-5301
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Stewart Goldman 773-880-4598 ext. 3270
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
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94143-1708
United States
Recruiting Daphne Haas-Kogan 415-353-7175
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Mark Kieran 617-632-4907
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 of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ian Pollack 412-692-5881
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 and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting J. Geyer 206-987-6664
Additional Information:
Study ID Numbers: CDR0000355177; PBTC-014
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079339
Other Untreated Childhood Brain Stem Glioma Studies:
1. Imatinib Mesylate With or Without Radiation Therapy in Treating Children With Newly Diagnosed or Recurrent Glioma
2. Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
3. Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
4. Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
5. Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Related Studies:
Other untreated childhood brain stem glioma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
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