ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplant in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: Children's Cancer and Leukaemia Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025077
  Purpose

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 transplant 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: This phase II trial is studying how well combination chemotherapy followed by surgery or radiation therapy and peripheral stem cell transplant work in treating patients with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carboplatin
Drug: cyclophosphamide
Drug: filgrastim
Drug: thiotepa
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Cyclophosphamide    Carboplatin    Filgrastim    Thiotepa   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Treatment Of Recurrent Central Nervous System Primitive Neuroectodermal Tumors (PNETs) In Children And Adolescents A Strategy Including The Use Of High Dose Thiotepa And High Dose Carboplatin

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxic death rate [ Designated as safety issue: Yes ]

Estimated Enrollment:   50
Study Start Date:   January 2000

Detailed Description:

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
Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025077

Locations
Ireland
Our Lady's Hospital for Sick Children Crumlin    
      Dublin, Ireland, 12
United Kingdom, England
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust    
      Cambridge, England, United Kingdom, CB2 2QQ
Birmingham Children's Hospital    
      Birmingham, England, United Kingdom, B4 6NH
Bristol Royal Hospital for Children    
      Bristol, England, United Kingdom, BS2 8BJ
Central Manchester and Manchester Children's University Hospitals NHS Trust    
      Manchester, England, United Kingdom, M27 4HA
Newcastle Upon Tyne Hospitals NHS Trust    
      Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Great Ormond Street Hospital for Children NHS Trust    
      London, England, United Kingdom, WC1N 3JH
Leeds Cancer Centre at St. James's University Hospital    
      Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary    
      Leicester, England, United Kingdom, LE1 5WW
Children's Hospital - Sheffield    
      Sheffield, England, United Kingdom, S10 2TH
Oxford Radcliffe Hospital    
      Oxford, England, United Kingdom, 0X3 9DU
Queen's Medical Centre    
      Nottingham, England, United Kingdom, NG7 2UH
Royal Liverpool Children's Hospital, Alder Hey    
      Liverpool, England, United Kingdom, L12 2AP
Royal Marsden NHS Foundation Trust - Surrey    
      Sutton, England, United Kingdom, SM2 5PT
Saint Bartholomew's Hospital    
      London, England, United Kingdom, EC1A 7BE
Southampton University Hospital NHS Trust    
      Southampton, England, United Kingdom, SO16 6YD
University College of London Hospitals    
      London, England, United Kingdom, WIT 3AA
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children    
      Belfast, Northern Ireland, United Kingdom, BT12 6BE
United Kingdom, Scotland
Aberdeen Royal Infirmary    
      Aberdeen, Scotland, United Kingdom, AB25 2ZN
Royal Hospital for Sick Children    
      Glasgow, Scotland, United Kingdom, G3 8SJ
Royal Hospital for Sick Children    
      Edinburgh, Scotland, United Kingdom, EH9 1LF

Sponsors and Collaborators
Children's Cancer and Leukaemia Group

Investigators
Study Chair:     Barry Pizer, MD     Royal Liverpool Children's Hospital, Alder Hey    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068910, CCLG-CNS-2000-01, EU-20105
First Received:   October 11, 2001
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00025077
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood supratentorial primitive neuroectodermal tumor  
recurrent childhood medulloblastoma  

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Carboplatin
Central Nervous System Neoplasms
Cyclophosphamide
Recurrence
Thiotepa
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Medulloblastoma
Neuroepithelioma
Glioma
Pinealoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers