Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303810
First received: March 15, 2006
Last updated: December 9, 2011
Last verified: July 2009
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which radiation therapy and combination chemotherapy regimen is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), or ependymoma.
PURPOSE: This clinical trial is studying six different radiation therapy and combination chemotherapy regimens to compare how well they work in treating young patients with medulloblastoma, PNET, or ependymoma.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide phosphate Drug: high-dose chemotherapy Drug: lomustine Drug: methotrexate Drug: thiotepa Drug: vincristine sulfate Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Therapy Optimizing Study for Treatment of Children and Adolescents With Intracranial Medulloblastoma / PNET and Ependymoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
Ewing sarcoma
MedlinePlus related topics:
Cancer
Drug Information available for:
Cyclophosphamide
Thiotepa
Methotrexate
Vincristine sulfate
Lomustine
Methotrexate sodium
Cisplatin
Etoposide
Carboplatin
Etoposide phosphate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 567 |
| Study Start Date: | January 2001 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare prognosis, using adapted risk stratification and quality control of diagnostic assessments and therapy, in pediatric patients with intracranial medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), or ependymoma treated with intensified chemotherapy and radiotherapy.
- Determine the effect of omission of radiotherapy, in terms of long-term sequelae, in young children with medulloblastoma and by hyperfractionation and reduction of radiotherapy in older children with medulloblastoma.
- Compare hyperfractionated radiotherapy with reduced-dose radiotherapy in older children with stage M0 medulloblastoma.
OUTLINE: This is a multi-protocol study. Patients are enrolled on 1 of 6 treatment protocols according to diagnosis and age at diagnosis.
- Protocol HIT-2000-AB4 (≥ 4 years old at diagnosis with nonmetastatic medulloblastoma)(phase III randomized controlled multicenter study): Patients are randomized to undergo hyperfractionated radiotherapy or conventional reduced-dose radiotherapy, followed by vincristine, lomustine, and cisplatin.
- Protocol HIT-2000-BIS4 (< 4 years old at diagnosis with nonmetastatic medulloblastoma): Patients receive 5 courses of cyclophosphamide, vincristine, methotrexate, carboplatin, etoposide phosphate, and intrathecal methotrexate. Patients with residual tumors after 3 courses undergo conventionally fractionated reduced-dose radiotherapy.
- Protocol MET-HIT-2000-AB4 (≥ 4 years old at diagnosis with metastatic medulloblastoma or supratentorial PNET): Patients receive combination chemotherapy as in HIT-2000-BIS4 for 2 courses. Patients then undergo hyperfractionated radiotherapy and receive combination chemotherapy as in HIT-2000-AB4. Patients with good response to combination chemotherapy (as in HIT-2000-BIS4) also receive high-dose chemotherapy.
- Protocol MET-HIT-2000-BIS4 (< 4 years old at diagnosis with metastatic medulloblastoma or supratentorial PNET): Patients receive 2-4 courses of carboplatin IV and etoposide phosphate IV continuously over 96 hours. Patients with partial or complete response also receive high-dose carboplatin, etoposide phosphate, cyclophosphamide, and thiotepa. Patients with residual tumor undergo conventional fractionated, reduced-dose radiotherapy.
- Protocol E-HIT-2000-AB4 (≥ 4 years old at diagnosis with intracranial ependymoma): Patients undergo local hyperfractionated radiotherapy. If histological grading shows WHO grade III tumor, patients also receive 5 courses of vincristine, cyclophosphamide, carboplatin, and etoposide phosphate.
- Protocol E-HIT-2000-BIS4 (< 4 years old at diagnosis with intracranial ependymoma): Patients receive 5 courses of cyclophosphamide, vincristine, methotrexate IV, carboplatin, and etoposide phosphate and then undergo conventional fractionated local radiotherapy.
PROJECTED ACCRUAL: A total of 567 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
- Medulloblastoma
- Supratentorial primitive neuroectodermal tumor (PNET)
- Ependymoma
Intracranial tumor
- No brain stem tumors
- No recurrent or relapsed tumors
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303810
Locations
| Germany | |
| University Medical Center Hamburg - Eppendorf | Recruiting |
| Wuerzburg, Germany, D-97080 | |
| Contact: Wiebke Treulieb 49-931-2012-7839 | |
Sponsors and Collaborators
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Investigators
| Study Chair: | Stefan Rutkowski, MD | Universitaets - Kinderklinik Wuerzburg |
| Investigator: | Frank Deinlein, MD | Universitaets - Kinderklinik Wuerzburg |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00303810 History of Changes |
| Other Study ID Numbers: | CDR0000455572, GPOH-HIT-2000, EU-205105 |
| Study First Received: | March 15, 2006 |
| Last Updated: | December 9, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
childhood infratentorial ependymoma childhood supratentorial ependymoma untreated childhood medulloblastoma newly diagnosed childhood ependymoma untreated childhood supratentorial primitive neuroectodermal tumor |
Additional relevant MeSH terms:
|
Ependymoma Medulloblastoma Nervous System Neoplasms Central Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Glioma Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
Etoposide phosphate Cisplatin Cyclophosphamide Etoposide Lomustine Methotrexate Thiotepa Vincristine Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013