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Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma



Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma

For Condition: childhood supratentorial ependymoma,newly diagnosed childhood ependymoma,childhood infratentorial ependymoma
Status: Recruiting
Sponsor(s): Societe Internationale d'Oncologie Pediatrique , United Kingdom Children's Cancer Study Group,Associazone Italiana Ematologia Oncologia Pediatrica
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 more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating children who have localizedependymoma.
Details: OBJECTIVES: - Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy. - Determine the response rate in these patients to this regimen. OUTLINE: This is a multicenter study. Patients undergo surgery to remove as much of tumor as possible. Patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy. Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8, and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses proceed to radiotherapy. If residual disease is still present at completion of chemotherapy, second look surgery is recommended. Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery. Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/20 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven nonmetastatic intracranial ependymoma - Cellular - Papillary - Clear cell - Mixed cell - Anaplastic - No myxopapillary ependymoma, subependymoma, or ependymoblastoma PATIENT CHARACTERISTICS: Age: - 3 to 20 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - No hematologic disease that would preclude study participation Hepatic: - Not specified Renal: - No renal disease that would preclude study participation Other: - No concurrent unrelated disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior steroids allowed Radiotherapy: - No prior radiotherapy Surgery: - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RichardGrundy,  Study Chair,  Birmingham Children's Hospital

Aberdeen Royal Infirmary *Recruiting*
Aberdeen,  Scotland,  AB25 2ZN
United Kingdom
Recruiting D.J.  King 44-1224-681-818

Queen's Medical Centre *Recruiting*
Nottingham,  England,  NG7 2UH
United Kingdom
Recruiting David  Walker 44-115-924-9924

Royal Liverpool Children's Hospital, Alder Hey *Recruiting*
Liverpool,  England,  L12 2AP
United Kingdom
Recruiting Heather  McDowell 44-151-228-4811

Manchester Children's Hospitals (NHS Trust) *Recruiting*
Manchester,  England,  M27 1HA
United Kingdom
Recruiting Bernadette  Brennan 44-161-727-2222

Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Milano (Milan),  ,  20133
Italy
Recruiting Maura  Massimino 39-02-239-02593

Oxford Radcliffe Hospital *Recruiting*
Oxford,  England,  0X3 9DU
United Kingdom
Recruiting Kate  Wheeler 44-186-522-1066

Children's Hospital - Sheffield *Recruiting*
Sheffield,  England,  S10 2TH
United Kingdom
Recruiting Mary  Gerrard 00-44-0114-271-7229

Royal Belfast Hospital for Sick Children *Recruiting*
Belfast,  Northern Ireland,  BT12 6BE
United Kingdom
Recruiting Anthony  Mccarthy 44-289-063-3631

Meyerstein Institute of Oncology at Middlesex Hospital *Recruiting*
London,  England,  WIT 3AA
United Kingdom
Recruiting Maria  Michelagnoli 44-20-7380-9950

Royal Hospital for Sick Children *Recruiting*
Edinburgh,  Scotland, 
United Kingdom
Recruiting Hamish  Wallace 0131-536-0426

Great Ormond Street Hospital for Children NHS Trust *Recruiting*
London,  England,  WC1N 3JH
United Kingdom
Recruiting Penelope  Brock 44-20-829-8832

Hospital for Sick Children *Recruiting*
Toronto,  Ontario,  M5G 1X8
Canada
Recruiting Eric  Bouffet 416-813-7457

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

Rigshospitalet *Recruiting*
Copenhagen,  ,  2100
Denmark
Recruiting H.  Carstensen 45-35451367

Ostra Sjukhuset *Recruiting*
Goteborg,  ,  41685
Sweden
Recruiting Brigitta  Lannering 46-31-343-5224

Saint Bartholomew's Hospital *Recruiting*
London,  England,  EC1A 7BE
United Kingdom
Recruiting Judith  Kingston 44-20-7943-1339

Our Lady's Hospital for Sick Children *Recruiting*
Crumlin,  ,  12
Ireland
Recruiting Fin  Breatnach 353-1-409-6659

Southampton General Hospital *Recruiting*
Southampton,  England,  SO16 6YD
United Kingdom
Recruiting Janice  Kohler 170-379-6942

Sophia Children's Hospital *Recruiting*
Rotterdam,  ,  3015 GJ
Netherlands
Recruiting R.  Reddingius 31-10-463-6363

Addenbrooke's NHS Trust *Recruiting*
Cambridge,  England,  CB2 2QQ
United Kingdom
Recruiting Denise  Williams 44-1223-216-878

Bristol Royal Hospital for Children *Recruiting*
Bristol,  England,  BS2 8BJ
United Kingdom
Recruiting Annabel  Foot 44-117-921-5411

Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia *Recruiting*
Buenos Aires,  ,  1428
Argentina
Recruiting Blanca  Diez 5411-5777-3200

Leicester Royal Infirmary *Recruiting*
Leicester,  England,  LE1 5WW
United Kingdom
Recruiting Rosemary  Shannon 44-116-254-1414

Royal Marsden Hospital - Sutton *Recruiting*
Sutton,  England,  SM2 5PT
United Kingdom
Recruiting Kathy  Pritchard-Jones 44-20-8661-3496

St. James's University Hospital *Recruiting*
Leeds,  England,  LS9 7TF
United Kingdom
Recruiting Adam  Glaser 44-113-206-4986

Hospital Des Cruces *Recruiting*
Vizcaya,  ,  48
Spain
Recruiting Aurora  Navajas 34-94-600-6000

Royal Hospital for Sick Children *Recruiting*
Glasgow,  Scotland,  G3 8SJ
United Kingdom
Recruiting E.M.  Simpson 44-141-201-0000

Birmingham Children's Hospital *Recruiting*
Birmingham,  England,  B4 6NH
United Kingdom
Recruiting Bruce  Morland 44-121-333-8233


Additional Information:
Study ID Numbers:
  CDR0000067465;  SIOP-EPENDYMOMA-99,AIEOP-EPENDYMOMA-99,UKCCSG-EPENDYMOMA-99,EU-99001
Study Start Date: 
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004224

Other Childhood Supratentorial Ependymoma Studies:
1. Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

2. Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children

3. Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors

4. Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

5. Antineoplaston Therapy in Treating Patients With Ependymoma

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