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Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor Clinical research trials and Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor. Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor  Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
For Condition: childhood rhabdoid tumor of the central nervous system,recurrent childhood supratentorial primitive neuroectodermal tumors,recurrent childhood ependymoma,recurrent childhood medulloblastoma
Status: Recruiting
Sponsor(s): Pediatric Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating children who have recurrent or refractorymedulloblastoma, supratentorialprimitive neuroectodermal or atypical teratoid rhabdoid tumor.
Details: OBJECTIVES: - Determine the objective response rate in pediatric patients with recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor treated with oxaliplatin. - Determine the objective response rate (complete and partial response) in patients with recurrent or progressive medulloblastoma at second or later relapse treated with this drug. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (medulloblastoma [measurable disease at first relapse vs positive cerebrospinal fluid or linear leptomeningeal disease vs measurable disease at second or later progression] vs supratentorial primitive neuroectodermal tumor vs atypical teratoid rhabdoid tumor). Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 1.5-2.8 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed medulloblastoma, supratentorial primitive neuroectodermal tumor (including pineoblastomas and ependymoblastomas), or atypical teratoid rhabdoid tumor - Recurrent or refractory disease - Measurable disease by radiography - Patients with positive cerebrospinal fluid cytology or linear leptomeningeal disease are eligible PATIENT CHARACTERISTICS: Age - 21 and under Performance status - Karnofsky 50-100% OR - Lansky 50-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) Hepatic - Bilirubin no greater than 1.5 times normal - ALT less than 2.5 times normal Renal - Creatinine no greater than 1.5 times normal OR - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Cardiovascular - Shortening fraction at least 27% by echocardiogram OR - Ejection fraction at least 50% by MUGA Pulmonary - No dyspnea at rest - No exercise intolerance - Pulse oximetry greater than 94% Other - No uncontrolled infection - No active graft-versus-host disease - No uncontrolled seizure disorders - Seizure disorders well controlled with anticonvulsants allowed - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 2 weeks since prior growth factors - At least 6 months since prior allogeneic stem cell transplantation - No concurrent colony-stimulating factors during the first course of study - No concurrent immunomodulating agents Chemotherapy - At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas) and recovered - No other concurrent anticancer chemotherapy Endocrine therapy - If concurrent corticosteroids necessary for intracranial pressure, must be on stable or decreasing dose for at least 1 week prior to study - No other concurrent corticosteroids Radiotherapy - At least 2 weeks since prior local palliative radiotherapy (small port) to symptomatic metastatic sites - At least 3 months since prior craniospinal radiotherapy - No concurrent palliative radiotherapy - Recovered from prior radiotherapy Surgery - Not specified Other - No other concurrent anticancer or experimental drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaryamFouladi, Study Chair, St. Jude Children's Research Hospital
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Susan Blaney 832-822-1482
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-9510
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Stewart Goldman 773-880-4598 ext. 3270
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting J. Geyer 206-987-6664
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Roger Packer 202-884-2120
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Mark Kieran 617-632-4907
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Amar Gajjar 901-495-4599
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 Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ian Pollack 412-692-5881
Additional Information:
Study ID Numbers: CDR0000257562; PBTC-010
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047177
Other Recurrent Childhood Medulloblastoma Studies:
1. Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
2. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
3. Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
4. Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Related Studies:
Other recurrent childhood medulloblastoma Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
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