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Spots Global Cancer Trial Database for Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplant in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors

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Trial Identification

Brief Title: Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplant in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors

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

Study ID: NCT00025077

Study Description

Brief Summary: 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.

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

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Our Lady's Hospital for Sick Children Crumlin, Dublin, , Ireland

Birmingham Children's Hospital, Birmingham, England, United Kingdom

Bristol Royal Hospital for Children, Bristol, England, United Kingdom

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Leicester Royal Infirmary, Leicester, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey, Liverpool, England, United Kingdom

Saint Bartholomew's Hospital, London, England, United Kingdom

Great Ormond Street Hospital for Children NHS Trust, London, England, United Kingdom

University College of London Hospitals, London, England, United Kingdom

Central Manchester and Manchester Children's University Hospitals NHS Trust, Manchester, England, United Kingdom

Newcastle Upon Tyne Hospitals NHS Trust, Newcastle-Upon-Tyne, England, United Kingdom

Queen's Medical Centre, Nottingham, England, United Kingdom

Oxford Radcliffe Hospital, Oxford, England, United Kingdom

Children's Hospital - Sheffield, Sheffield, England, United Kingdom

Southampton University Hospital NHS Trust, Southampton, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, United Kingdom

Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland, United Kingdom

Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom

Royal Hospital for Sick Children, Edinburgh, Scotland, United Kingdom

Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom

Contact Details

Name: Barry Pizer, MD

Affiliation: Royal Liverpool Children's Hospital, Alder Hey

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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