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

NCT00303810 | Completed

• 3 other identifiers: CDR0000455572GPOH-HIT-2000EU-205105
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood infratentorial ependymoma; childhood supratentorial ependymoma; untreated childhood medulloblastoma; newly diagnosed childhood ependymoma; untreated childhood supratentorial primitive neuroectodermal tumor

Interventions

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

etoposide phosphate DRUG

high-dose chemotherapy DRUG

lomustine DRUG

methotrexate DRUG

thiotepa DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

Location

Related Publications (6)

• von Bueren AO, von Hoff K, Pietsch T, Gerber NU, Warmuth-Metz M, Deinlein F, Zwiener I, Faldum A, Fleischhack G, Benesch M, Krauss J, Kuehl J, Kortmann RD, Rutkowski S. Treatment of young children with localized medulloblastoma by chemotherapy alone: results of the prospective, multicenter trial HIT 2000 confirming the prognostic impact of histology. Neuro Oncol. 2011 Jun;13(6):669-79. doi: 10.1093/neuonc/nor025.

  PMID: 21636711 RESULT

• Mynarek M, von Hoff K, Pietsch T, Ottensmeier H, Warmuth-Metz M, Bison B, Pfister S, Korshunov A, Sharma T, Jaeger N, Ryzhova M, Zheludkova O, Golanov A, Rushing EJ, Hasselblatt M, Koch A, Schuller U, von Deimling A, Sahm F, Sill M, Riemenschneider MJ, Dohmen H, Monoranu CM, Sommer C, Staszewski O, Mawrin C, Schittenhelm J, Bruck W, Filipski K, Hartmann C, Meinhardt M, Pietschmann K, Haberler C, Slavc I, Gerber NU, Grotzer M, Benesch M, Schlegel PG, Deinlein F, von Bueren AO, Friedrich C, Juhnke BO, Obrecht D, Fleischhack G, Kwiecien R, Faldum A, Kortmann RD, Kool M, Rutkowski S. Nonmetastatic Medulloblastoma of Early Childhood: Results From the Prospective Clinical Trial HIT-2000 and An Extended Validation Cohort. J Clin Oncol. 2020 Jun 20;38(18):2028-2040. doi: 10.1200/JCO.19.03057. Epub 2020 Apr 24.

  PMID: 32330099 DERIVED

• von Bueren AO, Kortmann RD, von Hoff K, Friedrich C, Mynarek M, Muller K, Goschzik T, Zur Muhlen A, Gerber N, Warmuth-Metz M, Soerensen N, Deinlein F, Benesch M, Zwiener I, Kwiecien R, Faldum A, Bode U, Fleischhack G, Hovestadt V, Kool M, Jones D, Northcott P, Kuehl J, Pfister S, Pietsch T, Rutkowski S. Treatment of Children and Adolescents With Metastatic Medulloblastoma and Prognostic Relevance of Clinical and Biologic Parameters. J Clin Oncol. 2016 Dec;34(34):4151-4160. doi: 10.1200/JCO.2016.67.2428. Epub 2016 Oct 31.

  PMID: 27863192 DERIVED

• Pompe RS, von Bueren AO, Mynarek M, von Hoff K, Friedrich C, Kwiecien R, Treulieb W, Lindow C, Deinlein F, Fleischhack G, Kuehl J, Rutkowski S. Intraventricular methotrexate as part of primary therapy for children with infant and/or metastatic medulloblastoma: Feasibility, acute toxicity and evidence for efficacy. Eur J Cancer. 2015 Nov;51(17):2634-42. doi: 10.1016/j.ejca.2015.08.009. Epub 2015 Sep 4.

  PMID: 26346136 DERIVED

• von Bueren AO, Friedrich C, von Hoff K, Kwiecien R, Muller K, Pietsch T, Warmuth-Metz M, Hau P, Benesch M, Kuehl J, Kortmann RD, Rutkowski S. Metastatic medulloblastoma in adults: outcome of patients treated according to the HIT2000 protocol. Eur J Cancer. 2015 Nov;51(16):2434-43. doi: 10.1016/j.ejca.2015.06.124. Epub 2015 Aug 5.

  PMID: 26254812 DERIVED

• Gerber NU, von Hoff K, Resch A, Ottensmeier H, Kwiecien R, Faldum A, Matuschek C, Hornung D, Bremer M, Benesch M, Pietsch T, Warmuth-Metz M, Kuehl J, Rutkowski S, Kortmann RD. Treatment of children with central nervous system primitive neuroectodermal tumors/pinealoblastomas in the prospective multicentric trial HIT 2000 using hyperfractionated radiation therapy followed by maintenance chemotherapy. Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):863-71. doi: 10.1016/j.ijrobp.2014.04.017.

  PMID: 24969797 DERIVED

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Carboplatin; Cisplatin; Cyclophosphamide; etoposide phosphate; Drug Therapy; Lomustine; Methotrexate; Thiotepa; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Therapeutics; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Stefan Rutkowski, MD

  University Med. Center Hamburg, Dpt. of Pediatric Hematology and Oncology

  STUDY CHAIR

• Frank Deinlein, MD

  Universitaets - Kinderklinik Wuerzburg

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: January 1, 2001
• Primary Completion: December 1, 2013
• Last Updated: January 28, 2014

Record last verified: 2009-07

Locations

DE (1)