|
Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors 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 Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors Clinical research trials and Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors 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 Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors. Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors 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 Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors 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 > "C" Clinical Trials Conditions > Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
For Condition: recurrent childhood supratentorial primitive neuroectodermal tumors,recurrent childhood medulloblastoma
Status: Recruiting
Sponsor(s): United Kingdom Children's Cancer Study Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery or radiation therapy may shrink the tumor so that it can be removed during surgery or radiation therapy. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy and allow doctors to give higher doses of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery or radiation therapy and peripheral stem cell transplantation in treating patients who have recurrentmedulloblastoma or primitive neuroectodermal and pineal tumors.
Details: OBJECTIVES: - Determine the feasibility of cyclophosphamide and surgical resection or radiotherapy followed by thiotepa, carboplatin, and autologous peripheral blood stem cell rescue in patients with recurrent medulloblastoma or supratentorial neuroectodermal and pineal tumors. - Determine the acute and chronic toxicity of this regimen in these patients. - Determine progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. - Cytoreductive Phase: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 7 and continuing until blood counts recover. Treatment repeats after discontinuation of G-CSF for 2-4 courses. Peripheral blood stem cells (PBSC) are harvested after each course of cyclophosphamide. Patients undergo surgical resection or radiotherapy after the completion of chemotherapy. Patients achieving complete response proceed to myeloablative therapy. - Myeloablative Phase: Patients receive thiotepa IV over 3 hours on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover. Beginning 2 days after the completion of G-CSF, patients receive carboplatin IV over 1 hour on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover. Patients are followed at 1, 3, 6, and 12 months. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /20 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent medulloblastoma or supratentorial primitive neuroectodermal and pineal tumor - Nodular/desmoplastic medulloblastoma - Medullomyoblastoma - Melanotic medulloblastoma - Ependymoblastoma - Pinealoblastoma - Received prior craniospinal radiotherapy OR - Relapse in site of prior localized radiotherapy (e.g., relapse after "baby brain" protocol) PATIENT CHARACTERISTICS: Age: - Under 21 Performance status: - Lansky 40-100% for ages 1-16 years - Karnofsky 40-100% for ages over 16 years Life expectancy: - At least 8 weeks Hematopoietic: - Neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than upper limit of normal (ULN) - AST less than 2 times ULN Renal: - Glomerular filtration rate at least 60 mL/min Other: - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarryPizer, Study Chair, Royal Liverpool Children's Hospital, Alder Hey
Royal Liverpool Children's Hospital, Alder Hey *Recruiting*
Liverpool, England, L12 2AP
United Kingdom
Recruiting Barry Pizer 051-2228-4811
Birmingham Children's Hospital *Recruiting*
Birmingham, England, B4 6NH
United Kingdom
Recruiting Bruce Morland 44-121-333-8233
Oxford Radcliffe Hospital *Recruiting*
Oxford, England, 0X3 9DU
United Kingdom
Recruiting Kate Wheeler 44-186-522-1066
Queen's Medical Centre *Recruiting*
Nottingham, England, NG7 2UH
United Kingdom
Recruiting David Walker 44-115-924-9924
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Adam Glaser 44-113-206-4986
Royal Hospital for Sick Children *Recruiting*
Glasgow, Scotland, G3 8SJ
United Kingdom
Recruiting E.M. Simpson 44-141-201-0000
Meyerstein Institute of Oncology at Middlesex Hospital *Recruiting*
London, England, WIT 3AA
United Kingdom
Recruiting Maria Michelagnoli 44-20-7380-9950
Aberdeen Royal Infirmary *Recruiting*
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Recruiting D.J. King 44-1224-681-818
Children's Hospital - Sheffield *Recruiting*
Sheffield, England, S10 2TH
United Kingdom
Recruiting Mary Gerrard 00-44-0114-271-7229
Leicester Royal Infirmary *Recruiting*
Leicester, England, LE1 5WW
United Kingdom
Recruiting Rosemary Shannon 44-116-254-1414
Royal Hospital for Sick Children *Recruiting*
Edinburgh, Scotland,
United Kingdom
Recruiting Hamish Wallace 0131-536-0426
Royal Belfast Hospital for Sick Children *Recruiting*
Belfast, Northern Ireland, BT12 6BE
United Kingdom
Recruiting Anthony Mccarthy 44-289-063-3631
Our Lady's Hospital for Sick Children *Recruiting*
Crumlin, , 12
Ireland
Recruiting Fin Breatnach 353-1-409-6659
Manchester Children's Hospitals (NHS Trust) *Recruiting*
Manchester, England, M27 1HA
United Kingdom
Recruiting Bernadette Brennan 44-161-727-2222
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Judith Kingston 44-20-7943-1339
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Denise Williams 44-1223-216-878
Southampton General Hospital *Recruiting*
Southampton, England, SO16 6YD
United Kingdom
Recruiting Janice Kohler 170-379-6942
Great Ormond Street Hospital for Children NHS Trust *Recruiting*
London, England, WC1N 3JH
United Kingdom
Recruiting Penelope Brock 44-20-829-8832
Newcastle Upon Tyne Hospitals NHS Trust *Recruiting*
Newcastle upon Tyne, England, NE7 7DN
United Kingdom
Recruiting Andrew J. Pearson 44-191-232-5131 ext. 24101
Bristol Royal Hospital for Children *Recruiting*
Bristol, England, BS2 8BJ
United Kingdom
Recruiting Annabel Foot 44-117-921-5411
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting Kathy Pritchard-Jones 44-20-8661-3496
Additional Information:
Study ID Numbers: CDR0000068910; UKCCSG-CNS-2000-01,EU-20105
Study Start Date:
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025077
Other Recurrent Childhood Medulloblastoma Studies:
1. Docetaxel in Treating Children With Recurrent Solid Tumors
2. Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
3. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
4. Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
5. Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
Related Studies:
Other recurrent childhood medulloblastoma Clinical Trials
Other Clinical Trials
Other Crumlin Clinical Trials
Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
|
|
|
|
|
|
|
|