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Busulfan in Treating Children and Adolescents With Refractory CNS Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Busulfan in Treating Children and Adolescents With Refractory CNS Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Busulfan in Treating Children and Adolescents With Refractory CNS Cancer Clinical research trials and Busulfan in Treating Children and Adolescents With Refractory CNS Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Busulfan in Treating Children and Adolescents With Refractory CNS Cancer. Busulfan in Treating Children and Adolescents With Refractory CNS Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Busulfan in Treating Children and Adolescents With Refractory CNS Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Busulfan in Treating Children and Adolescents With Refractory CNS Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Busulfan in Treating Children and Adolescents With Refractory CNS Cancer  Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
For Condition: Lymphoma,Leukemia,Brain Tumor
Status: No longer 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 I trial to study the effectiveness of intrathecal busulfan in treating children and adolescents who have refractory CNS cancer.
Details: OBJECTIVES: - Determine the qualitative and quantitative toxicities of intrathecally administered busulfan in children and adolescents with refractory CNS malignancies. - Determine the maximum tolerated dose of this treatment regimen in these patients. - Determine the cerebrospinal fluid and serum pharmacokinetics of this treatment regimen in these patients. - Determine the efficacy of this treatment regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive intrathecal busulfan twice a week, at least 3 days apart, for 2 weeks. Patients with complete or partial response or stable disease may continue therapy once a week for 2 weeks, once a week every other week for 2 treatments, and then once a month thereafter in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of busulfan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for the first year, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study over 18-38 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed CNS malignancy, including any of the following: - Primary malignant brain tumor refractory to standard therapy and metastatic to the cerebrospinal fluid (CSF) or leptomeningeal subarachnoid space - Recurrent or persistent leptomeningeal leukemia, lymphoma, or germ cell tumor refractory to conventional therapy - In second or greater relapse - CSF white blood count greater than 5 cells/mm3 with blasts on cytospin OR - Evidence of leptomeningeal tumor by MRI - No concurrent bone marrow disease - No obstruction or compartmentalization of CSF flow on CSF flow study PATIENT CHARACTERISTICS: Age: - 3 to 21 Performance status: - Lansky 50-100% (under 10 years) - Karnofsky 50-100% (10 to 21 years) Life expectancy: - Greater than 8 weeks Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 75,000/mm^3 Hepatic: - Bilirubin normal for age - ALT and AST less than 5 times upper limit of normal (ULN) - No hepatic disease Renal: - Creatinine no greater than 1.5 times ULN OR - Glomerular filtration rate greater than 70 mL/min - No renal disease Cardiovascular: - No cardiac disease Pulmonary: - No pulmonary disease Other: - No uncontrolled infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) - At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine) and recovered - Evidence of subsequent disease progression - Concurrent systemic chemotherapy allowed for recurrent disease after first course of treatment except for the following: - Chemotherapy targeted at leptomeningeal disease - Other phase I agent - Any agent that significantly penetrates the CSF (e.g., high dose methotrexate greater than 1 g/m2, thiotepa, high dose cytarabine, fluorouracil, IV mercaptopurine, nitrosoureas, or topotecan) - Any agent that causes serious unpredictable CNS side effects Endocrine therapy: - Prior dexamethasone allowed with decreasing or stable dose at least one week before study - Concurrent dexamethasone or prednisone with chemotherapy regimen allowed Radiotherapy: - At least 1 week since prior focal irradiation to the brain or spine - At least 8 weeks since prior craniospinal irradiation - No concurrent cranial or craniospinal irradiation Surgery: - Not specified Other: - No other concurrent intrathecal or systemic therapy for leptomeningeal disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SriGururangan, Study Chair, Duke Comprehensive Cancer Center
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: CDR0000068178; PBTC-004
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006246
Other Brain Tumor Studies:
1. Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma
2. Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma
3. Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation
4. Phase II Liposomal Vincristine for Pediatric and Adolescent Patients with Relapsed Malignancies
5. Biological Therapy in Treating Patients Undergoing Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation for Hematologic Cancer
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Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
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