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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

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