Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma - Full Text View

Sponsored by:	Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303810

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

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Cyclophosphamide Thiotepa Vincristine Methotrexate Lomustine Cisplatin Etoposide Carboplatin Etoposide phosphate Vincristine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Multicenter Therapy Optimizing Study for Treatment of Children and Adolescents With Intracranial Medulloblastoma / PNET and Ependymoma

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)

Detailed Description:

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
Universitaets - Kinderklinik Wuerzburg	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:

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

No publications provided

Study ID Numbers:	CDR0000455572, GPOH-HIT-2000, EU-205105
Study First Received:	March 15, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00303810 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Neuroectodermal Tumors, Primitive
Immunologic Factors
Lomustine
Cyclophosphamide
Central Nervous System Neoplasms
Etoposide phosphate
Ependymoma
Cisplatin
Neoplasms, Germ Cell and Embryonal
Methotrexate
Neuroepithelioma
Glioma
Etoposide
Alkylating Agents

Nervous System Neoplasms
Vincristine
Antimitotic Agents
Carboplatin
Folic Acid Antagonists
Immunosuppressive Agents
Thiotepa
Folic Acid
Neuroectodermal Tumors
Tubulin Modulators
Medulloblastoma
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Reproductive Control Agents
Central Nervous System Neoplasms
Cyclophosphamide
Etoposide phosphate
Ependymoma
Neoplasms by Site
Therapeutic Uses

Neoplasms, Germ Cell and Embryonal
Abortifacient Agents
Methotrexate
Glioma
Dermatologic Agents
Alkylating Agents
Etoposide
Nucleic Acid Synthesis Inhibitors
Nervous System Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Nervous System Diseases
Vincristine
Enzyme Inhibitors
Antimitotic Agents

ClinicalTrials.gov processed this record on May 07, 2009