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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602667 |
RATIONALE: 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. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with erlotinib and radiation therapy may kill more tumor cells.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system tumors.
Condition | Intervention |
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Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: erlotinib hydrochloride Drug: etoposide Drug: filgrastim Drug: leucovorin calcium Drug: methotrexate Drug: topotecan hydrochloride Drug: vinblastine Drug: vincristine sulfate Procedure: DNA analysis Procedure: fluorescence in situ hybridization Procedure: gene expression analysis Procedure: gene expression profiling Procedure: high performance liquid chromatography Procedure: immunohistochemistry staining method Procedure: liquid chromatography Procedure: loss of heterozygosity analysis Procedure: mass spectrometry Procedure: mutation analysis Procedure: polyacrylamide gel electrophoresis Procedure: polymerase chain reaction Procedure: polymorphism analysis Procedure: protein expression analysis Procedure: radiation therapy Procedure: reverse transcriptase-polymerase chain reaction Procedure: western blotting |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Risk-Adapted Therapy for Children Less Than 3 Years of Age With Embryonal Brain Tumors, Choroid Plexus Carcinoma or Ependymoma |
Estimated Enrollment: | 140 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 2 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed CNS tumors of any of the following :
Meets criteria for 1 of the following risk groups:
Low-risk group:
Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity
No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF)
Intermediate-risk group:
High-risk group:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Clinical Trials Office - St. Jude Children's Research Hospital 901-495-4644 |
Study Chair: | Robert P. Sanders, MD | St. Jude Children's Research Hospital |
Study ID Numbers: | CDR0000580360, SJCRH-SJYC07 |
Study First Received: | January 10, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00602667 |
Health Authority: | Unspecified |
untreated childhood medulloblastoma untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood pineoblastoma |
childhood atypical teratoid/rhabdoid tumor childhood choroid plexus tumor newly diagnosed childhood ependymoma |
Choroid Plexus Neoplasms Rhabdoid Tumor Neuroectodermal Tumors, Primitive Leucovorin Vinblastine Central Nervous System Neoplasms Cyclophosphamide Etoposide phosphate Ependymoma Cisplatin Neuroepithelioma Methotrexate Choroid Plexus neoplasms |
Etoposide Nervous System Neoplasms Erlotinib Vincristine Carboplatin Rhabdoid tumor Carcinoma Folic Acid Neuroectodermal Tumors Brain Neoplasms Calcium, Dietary Medulloblastoma Topotecan |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Protein Kinase Inhibitors Neoplasms by Site Therapeutic Uses Vitamins Abortifacient Agents Micronutrients Alkylating Agents Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Vitamin B Complex Growth Substances Mitosis Modulators Nervous System Diseases Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating |