|
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas Clinical research trials and Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas. Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas clinical trial. Subjects frequently obtain the most expert healthcare possible for their Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas  Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
For Condition: untreated childhood brain stem glioma
Status: Suspended
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 carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
Details: OBJECTIVES: - Determine the maximum tolerated duration of lobradimil plus carboplatin with radiotherapy in patients with newly diagnosed brain stem gliomas. - Determine the toxic effects of this treatment regimen in these patients. - Assess the response to radiotherapy in patients treated with this regimen. OUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV over 10 minutes concurrently with radiotherapy. The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until unacceptable toxicity occurs in 2 of 6 patients. Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and then annually thereafter. PROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study within 36 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 gliomas - Measurable disease - No disseminated disease at sites other than brain stem - No neurofibromatosis - Treatment must begin within 31 days of diagnosis - Date of diagnosis will be considered date of surgery in patients undergoing surgical biopsy PATIENT CHARACTERISTICS: Age: - 3 to 21 Performance status: - Karnofsky 50-100% (over 10 years of age) - Lansky 50-100% (10 years of age and under) Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGPT no greater than 2.5 times ULN (4.0 times ULN with antiepileptic or steroid medications) Renal: - Creatinine less than ULN for age OR - Creatinine clearance or glomerular filtration rate greater than 80 mL/min Other: - No history of severe allergic reaction to any platinum-containing compound - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent growth factors during therapy with carboplatin Chemotherapy - Not specified Endocrine therapy - Prior corticosteroids for brain stem glioma are allowed Radiotherapy - Not specified Surgery - Prior surgery for brain stem glioma is allowed Other - At least 24 hours since any of the following medications: - Vasodilating compounds - Angiotensin-converting enzyme inhibitors - Calcium channel blockers - Beta blockers - No other prior therapy for brain stem glioma
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RogerPacker, Study Chair, Children's National Medical Center
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Additional Information:
Study ID Numbers: CDR0000067715; CCG-ADVL0012,COG-ADVL0012,ALK-01-042,CCG-09802
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005602
Other Untreated Childhood Brain Stem Glioma Studies:
1. Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
2. Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
3. Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
4. Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
5. Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
Related Studies:
Other untreated childhood brain stem glioma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
|
|
|
|
|
|
|
|
