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O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors Clinical research trials and O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors clinical trial. Test subjects typically obtain the finest healthcare available for their O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors  O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
For Condition: childhood choroid plexus tumor,recurrent childhood cerebral astrocytoma,recurrent childhood ependymoma,childhood central nervous system germ cell tumor,Childhood Oligodendroglioma,recurrent childhood brain stem glioma,recurrent childhood medulloblastoma,recurrent childhood cerebellar astrocytoma,recurrent childhood visual pathway glioma,childhood craniopharyngioma,recurrent childhood supratentorial primitive neuroectodermal and pineal tumors
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Pediatric Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating children who have refractory CNS tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicity of carmustine administered after O6-benzylguanine in children with refractory primary CNS tumors. II. Determine a safe and tolerable dose of carmustine administered after O6-benzylguanine to be used in phase II studies. III. Determine the pharmacokinetics of O6-benzylguanine and its metabolite, O6-benzyl-8-oxoguanine, in these patients. IV. Seek preliminary evidence of antitumor activity of this regimen in these patients. V. Evaluate the acute and chronic toxicities, and describe cumulative toxicity, in patients treated with multiple courses of this regimen. PROTOCOL OUTLINE: This is a dose escalation study of carmustine. Patients receive O6-benzylguanine IV over 1 hour, then, 1 hour later, carmustine IV is administered over 1 hour. Treatment is repeated every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of carmustine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose level at which fewer than 2 of 6 patients experience dose limiting toxicity (DLT). If myelosuppression is the DLT, stratum 1 is closed and patients are accrued to stratum 2. If neutropenia is the DLT in stratum 2, patients receive filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until blood counts recover. Patients are followed every 6 months for 4 years, then annually thereafter. PROJECTED ACCRUAL: Approximately 3-36 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven CNS tumor that is refractory to conventional therapy or for which no effective therapy is known; Histological requirement may be waived for brainstem and optic gliomas - Stratum 2: No bone marrow involvement --Prior/Concurrent Therapy-- - Biologic therapy: At least 7 days since prior biologic therapy or immunotherapy and recovered; At least 6 months since prior bone marrow transplant (stratum 1 only); At least 7 days since prior growth factors; No concurrent filgrastim (G-CSF) prophylaxis; Stratum 2: No prior bone marrow transplantation - Chemotherapy: At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered; Stratum 2: No greater than 2 prior chemotherapy regimens; No prior nitrosourea therapy - Endocrine therapy: If receiving dexamethasone, must be on stable or decreasing dose for at least 2 weeks prior to study - Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port); At least 6 months since prior substantial bone marrow radiation, total body irradiation, hemipelvic radiotherapy, or total abdominal/pelvic/chest or mantle/Y ports radiotherapy Recovered from prior radiotherapy; Stratum 2: No prior central axis radiation - Surgery: Not specified - Other: No other concurrent anticancer or investigational agents --Patient Characteristics-- - Age: 21 and under - Performance status: Karnofsky 50-100% OR Lansky 50-100% - Life expectancy: At least 8 weeks - Hematopoietic: Absolute neutrophil count at least 1500/mm3; Platelet count at least 100,000/mm3 (stratum 2: at least 125,000/mm3); Hemoglobin at least 8 g/dL - Hepatic: Bilirubin less than 1.5 mg/dL; SGOT/SGPT no greater than 2.5 times normal - Renal: Creatinine or GFR normal for age - Pulmonary: If required, DLCO must be 80% of normal and patient old enough to cooperate for DLCO test - Other: Neurologic deficits must be stable for at least 2 weeks prior to study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeniseAdams, Study Chair, Pediatric Oncology Group
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
City of Hope National Medical Center
Los Angeles, California, 91010
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Graham Children's Health Center
Asheville, North Carolina, 28801
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Additional Information:
Study ID Numbers: CDR0000066891; POG-9870
Study Start Date: May 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003765
Other Recurrent Childhood Supratentorial Primitive Neuroectodermal And Pineal Tumors Studies:
1. Combination Chemotherapy in Treating Children With Progressive Brain Tumors
2. Docetaxel in Treating Children With Recurrent Solid Tumors
3. High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas
4. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
5. Vinorelbine in Treating Children With Recurrent or Refractory Cancers
Related Studies:
Other recurrent childhood supratentorial primitive neuroectodermal and pineal tumors Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
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