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Cilengitide in Treating Children With Refractory Primary Brain Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Cilengitide in Treating Children With Refractory Primary Brain Tumors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Cilengitide in Treating Children With Refractory Primary Brain Tumors Clinical research trials and Cilengitide in Treating Children With Refractory Primary Brain Tumors health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Cilengitide in Treating Children With Refractory Primary Brain Tumors. Cilengitide in Treating Children With Refractory Primary Brain Tumors Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Cilengitide in Treating Children With Refractory Primary Brain Tumors clinical trial. Participants oftentimes recieve the most expert healthcare available for their Cilengitide in Treating Children With Refractory Primary Brain Tumors condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cilengitide in Treating Children With Refractory Primary Brain Tumors  Cilengitide in Treating Children With Refractory Primary Brain Tumors
Cilengitide in Treating Children With Refractory Primary Brain Tumors
For Condition: childhood brain tumor,childhood spinal cord tumors,childhood meningioma
Status: Recruiting
Sponsor(s): Pediatric Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Cilengitide may slow the growth of brain cancer cells by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of cilengitide in treating children who have recurrent, progressive, or refractoryprimaryCNS tumors.
Details: OBJECTIVES: - Determine the acute and dose-limiting toxic effects of cilengitide (EMD 121974) in children with refractory primary brain tumors. - Determine the maximum tolerated dose of this drug in these patients. - Determine the inter- and intra-patient variability in the pharmacokinetics of this drug and estimate its renal clearance in these patients. - Correlate the changes in circulating endothelial cells and circulating endothelial precursors with plasma, serum, and urine angiogeneic protein levels and with clinical outcome in patients treated with this drug. - Determine, preliminarily, the efficacy and biologic activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive cilengitide (EMD 121974) IV over 1 hour twice weekly. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cilengitide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 25% of patients are expected to experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients are accrued and treated at that dose level. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1-1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary central nervous system (CNS) tumor, including histologically benign CNS tumors (e.g., low-grade gliomas)* - Recurrent or progressive disease - Refractory to standard therapy NOTE: *In the absence of histological diagnosis, clinical and radiographic evidence of a brain stem glioma is required - Patients with bone marrow involvement may be eligible PATIENT CHARACTERISTICS: Age - 21 and under Performance status - Karnofsky 50-100% OR - Lansky 50-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3 (transfusion independent) - Hemoglobin greater than 8.0 g/dL (transfusion allowed) Hepatic - Bilirubin normal - ALT and AST less than 2.5 times upper limit of normal - No overt hepatic disease Renal - Creatinine less 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 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Neurological deficits allowed provided that they are stable for at least 1 week before study entry - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy - More than 1 week since prior growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) - More than 6 months since prior bone marrow transplantation - More than 2 weeks since prior biological agents Chemotherapy - At least 6 weeks since prior nitrosoureas Endocrine therapy - Concurrent corticosteroids allowed provided that they are at a stable dose for at least 1 week before study entry Radiotherapy - At least 6 weeks since prior radiotherapy - More than 2 weeks since prior local palliative radiotherapy - More than 3 months since prior craniospinal (more than 24 Gy) or total body radiotherapy Surgery - Not specified Other - Recovered from prior therapy - More than 2 weeks since prior investigational agents - At least 4 weeks since prior myelosuppressive therapy - Concurrent anticonvulsants allowed - No other concurrent anticancer agents or therapies - No other concurrent experimental agents or therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TobeyMacDonald, Study Chair, Children's National Medical Center
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
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
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Roger Packer 202-884-2120
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
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Mark Kieran 617-632-4907
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ian Pollack 412-692-5881
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-9510
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
Additional Information:
Study ID Numbers: CDR0000305859; PBTC-012
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063973
Other Childhood Brain Tumor Studies:
1. Cilengitide in Treating Children With Refractory Primary Brain Tumors
2. Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors
3. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
4. SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
5. Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, or Gliosarcoma
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Cilengitide in Treating Children With Refractory Primary Brain Tumors
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