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Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma Clinical research trials and Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma. Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma  Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
For Condition: untreated childhood brain stem glioma
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosedbrain stem glioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma. - Determine the toxic effects of this drug given at the MTD in these patients. - Determine the intratumor and brain distribution of this drug by MRI in these patients. OUTLINE: This is a dose-escalation study of motexafin gadolinium. Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks. Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for up to 3 years. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Clinically and radiographically (MRI) proven newly diagnosed diffuse intrinsic brainstem glioma - Greater than 50% intra-axial involvement of the pons, pons and medulla, pons and midbrain, or entire brainstem - Contiguous involvement of the thalamus or upper cervical cord allowed PATIENT CHARACTERISTICS: Age: - 21 and under Performance status: - ECOG 0-2 Life expectancy: - More than 2 months Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL (transfusion allowed) - No glucose 6 phosphate dehydrogenase deficiency Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT or SGPT less than 1.5 times normal Renal: - Creatinine no greater than 1.5 times normal OR - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunomodulating agents Chemotherapy: - No other concurrent chemotherapy Endocrine therapy: - Concurrent corticosteroid therapy allowed for increased intracranial pressure only Radiotherapy: - No prior cranial radiotherapy Surgery: - Not specified Other: - No prior motexafin gadolinium - No other concurrent experimental agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MineshMehta, Study Chair, University of Wisconsin Comprehensive Cancer Center
Princess Margaret Hospital for Children *Recruiting*
Perth, Western Australia, 6001
Australia
Recruiting David Baker 61-8-9340-8234
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5208
United States
Recruiting Michael Link 650-723-5535
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Arthur Ritchey 412-692-5949
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Nita Seibel 202-884-2144
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Albert Moghrabi 514-345-4969
Children's Hospital of Orange County *Recruiting*
Orange, California, 92868
United States
Recruiting Wei-Ping Shen 714-532-8636
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Ronald Dubowy 315-464-5294
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting John Perentesis 513-636-6090
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Robert Fallon 317-274-8784
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brenda Weigel 612-626-8484
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Victor Blanchette 416-598-5852
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Stephen Feig 310-825-5268
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Douglas Hawkins 206-987-3096
Additional Information:
Study ID Numbers: CDR0000067087; COG-A09712,CCG-09712
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003909
Other Untreated Childhood Brain Stem Glioma Studies:
1. Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
2. Imatinib Mesylate With or Without Radiation Therapy in Treating Children With Newly Diagnosed or Recurrent Glioma
3. Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
4. Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
5. Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
Related Studies:
Other untreated childhood brain stem glioma Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
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