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Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma Clinical research trials and Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma. Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma clinical trial. Human subjects often receive the most effective healthcare possible for their Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma  Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Paclitaxel 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 Hospital of Philadelphia ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of paclitaxel when combined with involved-field radiotherapy in children with newly diagnosed, diffuse, intrinsic brain stem glioma. - Determine the toxicity of this regimen in these patients. - Assess the antitumor activity of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of paclitaxel. Patients receive induction therapy comprising paclitaxel IV over 1 hour once weekly and involved-field radiotherapy (after paclitaxel infusion) once daily, 5 days a week, for 6 weeks. Beginning 6 weeks after completion of induction therapy, patients may receive maintenance therapy comprising paclitaxel IV over 1 hour once every 3 weeks for a total of 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. 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 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and MRI - Histologic verification not required - Intrinsic (more than 50% intra-axial) involvement of the pons, pons and medulla, pons and midbrain, or entire brain stem allowed - Contiguous involvement of the thalamus or upper cervical cord allowed PATIENT CHARACTERISTICS: Age: - 3 to 21 at diagnosis Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,000/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin greater than 10.0 g/dL Hepatic: - Bilirubin less than 1.5 times normal - SGOT or SGPT less than 2.5 times normal Renal: - Creatinine less than 1.5 times normal Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use a highly effective method of contraception for female patients or barrier contraception for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No other concurrent anticancer chemotherapy Endocrine therapy: - Concurrent corticosteroid therapy for increased intracranial pressure allowed Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent cytochrome P450-inducing anticonvulsants (e.g., phenytoin or carbamazepine) during paclitaxel therapy - Other concurrent anticonvulsants (e.g., valproic acid) for pre-existing seizure disorder allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanBelasco, Study Chair, Children's Hospital of Philadelphia
Beth Israel Medical Center - Singer Division *Recruiting*
New York City, New York, 10128
United States
Recruiting Jeffrey Allen 212-870-9407
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jean Belasco 215-590-2848
New York University Medical Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Jonathan Finlay 212-263-6725/6829
Additional Information:
Study ID Numbers: CDR0000069064; BMS-CHP-623,NCI-V01-1677,CHP-623,CHP-1999-7-1780
Study Start Date:
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031577
Other Untreated Childhood Brain Stem Glioma Studies:
1. Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
2. Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
3. Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
4. Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
5. Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
Related Studies:
Other untreated childhood brain stem glioma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
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