|
Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors Clinical research trials and Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors. Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors  Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors
Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors
For Condition: Neuroblastoma,childhood brain tumor
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and radiation therapy in treating infants who have tumors of the brain.
Details: OBJECTIVES: - Assess the feasibility of the addition of regional therapy with intrathecal (IT) mafosfamide to an intensive regimen of systemic chemotherapy in children under 3 years of age at diagnosis with medulloblastoma/primitive neuroectodermal tumor, ependymoma with metastatic disease, or other primary intracranial embryonal tumors. - Determine the safety and feasibility of a limited dose- escalation schedule of IT mafosfamide in this patient population. - Assess the feasibility, including expected disease progression, of delivering 20 weeks of systemic chemotherapy plus IT mafosfamide in this patient population. - Determine the subsequent progression-free survival and pattern of failure associated with the use of IT mafosfamide and conformal irradiation to the local tumor region followed by 2 further courses of systemic chemotherapy among these patients with initially local disease (M0) at diagnosis. - Develop preliminary estimates of the local and neuraxis response rate to intensive postoperative systemic/regional chemotherapy in these patients. - Determine the acute and chronic toxic effects associated with the delivery of the first 20 weeks of this chemotherapy in these patients. - Determine whether the first 10 weeks of systemic chemotherapy can restore normal CSF flow, thus permitting administration of IT mafosfamide during the second 10 weeks of systemic chemotherapy in patients initially ineligible to receive IT mafosfamide because of subarachnoid block by tumor. - Assess the pharmacokinetics of IT mafosfamide using a limited sampling strategy in these patients. - Determine the concentration of matrix metalloproteinases (MMPs) in the CSF of these patients. OUTLINE: This is a multicenter, dose-escalation study of mafosfamide. All patients receive regimen 1 chemotherapy. Children whose tumor is limited to 1 area at the beginning of the study proceed to radiotherapy and then regimen 2 chemotherapy. Children whose tumor is found in more than 1 part of the brain or in the CSF at the beginning of the study complete treatment after regimen 1 chemotherapy. - Children with normal CSF flow at the beginning of the study receive regimen 1 chemotherapy along with intrathecal (IT) mafosfamide. Children with abnormal CSF flow receive regimen 1 without IT mafosfamide. Patients with initially abnormal CSF flow who show no evidence of obstructive hydrocephalus or compartmentalization on the repeat study receive IT mafosfamide beginning with course 2. Patients receive cyclophosphamide IV over 30 minutes twice weekly on weeks 1, 4, 11, and 14, vincristine IV once weekly on weeks 1-6 and 11-16, cisplatin IV over 6 hours once weekly on weeks 1, 4, 11, and 14, and oral etoposide once weekly on weeks 7-9 and 17-19. IT mafosfamide is administered twice weekly on weeks 1-6 and then once weekly on weeks 7-9, 11, 14, and 17. Patients are evaluated at weeks 10 and 20. After completion of regimen 1, patients may undergo surgery to remove more of their tumor. Patients who are initially M0 with stable or responding disease begin conformal radiotherapy 2 weeks after completing regimen 1 chemotherapy or second surgery. Patients receive radiotherapy once daily 5 days a week. - Regimen 2: After completing radiotherapy, patients receive cyclophosphamide IV over 30 minutes twice weekly on weeks 1, 4, 11, and 14, vincristine IV once weekly on weeks 1-6 and 11-16, and oral etoposide once weekly on weeks 7-9 and 17-19. Patients are evaluated at weeks 10 and 20. Cohorts of 3-6 patients receive escalating doses of IT mafosfamide during regimen 1 chemotherapy 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 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 86-95 patients will be accrued for this study within 4-5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /2 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary intracranial CNS medulloblastoma/primitive neuroectodermal tumor or other embryonal tumor (medulloepithelioma, ependymoblastoma, neuroblastoma, pineoblastoma), atypical teratoid/rhabdoid tumor, intracranial germ cell tumor, choroid plexus tumor, or metastatic ependymoma - If positive bone scan, pre-treatment bone marrow aspirate and biopsy must be free of tumor PATIENT CHARACTERISTICS: Age: - Under 3 Performance status: - Karnofsky 30-100% OR - Lansky 30-100% Life expectancy: - Not specified Hematopoietic: - Hemoglobin at least 10 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL - SGPT less than 5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance greater than 40 mL/min Other: - Willing to have a central line - Willing to have CSF flow study to determine whether or not they will receive intrathecal chemotherapy - Willing to have Ommaya reservoir placed if needed PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior steroids allowed Radiotherapy: - No prior radiotherapy Surgery: - No more than 35 days since prior definitive surgery Other: - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanBlaney, Study Chair, Texas Children's Cancer Center
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting J. Geyer 206-987-6664
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Roger Packer 202-884-2120
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Henry Friedman 919-684-5301
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Mark Kieran 617-632-4907
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-9510
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ian Pollack 412-692-5881
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Phillips 215-590-2107
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting James Boyett 901-495-3370
Additional Information:
Study ID Numbers: CDR0000067667; PBTC-001
Study Start Date:
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005063
Other Neuroblastoma Studies:
1. Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
2. CHP677: I-Metaiodobenzylguanidine (I-MIBG) therapy for refractory neuroblastoma: a Phase II study
3. Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
4. Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
5. Monoclonal Antibody Therapy After Allogeneic Stem Cell Transplantation in Treating Patients With Persistent or Progressive Cancer
Related Studies:
Other Neuroblastoma Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Chemotherapy and Radiation Therapy in Treating Infants With Brain Tumors
|
|
|
|
|
|
|
|
