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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Event-free survival [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Event-free survival | ||||
| Change History | Complete list of historical versions of study NCT00025077 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Toxic death rate [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Toxic death rate | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 ICMJE | 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 | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed at 1, 3, 6, and 12 months. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Brain and Central Nervous System Tumors | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||
| Ages | up to 20 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Ireland, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00025077 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068910, CCLG-CNS-2000-01, EU-20105 | ||||
| Study Sponsor ICMJE | Children's Cancer and Leukaemia Group | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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