Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Central Nervous System Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsored by: St. Jude Children's Research Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00602667
  Purpose

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
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

MedlinePlus related topics: Cancer
Drug Information available for: Cyclophosphamide Carboplatin Filgrastim Etoposide Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Vincristine sulfate Vincristine Cisplatin Topotecan hydrochloride Topotecan Erlotinib Erlotinib hydrochloride Etoposide phosphate Calcium gluconate Vinblastine Vinblastine sulfate
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: Yes ]
  • Event-free survival [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Relationship of chromosomal abnormalities and gene expression patterns to other clinicopathological variables [ Designated as safety issue: No ]
  • Presence of molecular abnormalities with suspected prognostic or therapeutic significance [ Designated as safety issue: No ]
  • Collection of frozen and fixed tumor samples for analysis [ Designated as safety issue: No ]
  • Event-free and overall survival of study patients compared to historical controls [ Designated as safety issue: Yes ]
  • Rates of local and distant disease progression in patients treated with focal radiotherapy [ Designated as safety issue: No ]
  • Objective response rate (sustained for 8 weeks) to induction chemotherapy including high-dose intravenous methotrexate for patients with residual or metastatic disease [ Designated as safety issue: No ]
  • Feasibility and toxicity of administering low-dose intravenous vinblastine in patients with metastatic disease [ Designated as safety issue: Yes ]
  • Feasibility and toxicity of administering consolidation therapy including cyclophosphamide and pharmacokinetically targeted topotecan to patients with metastatic disease [ Designated as safety issue: Yes ]
  • Sustained (for 8 weeks) objective response rate (complete response and partial response) to such therapy in patients with measurable residual disease after induction [ Designated as safety issue: No ]
  • Feasibility and toxicity of administering oral maintenance therapy in children younger than three years of age at diagnosis [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: November 2007
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed CNS tumors of any of the following :

    • Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic medulloblastoma)
    • Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma)
    • Pineoblastoma
    • Atypical teratoid rhabdoid tumor (ATRT)
    • Choroid plexus carcinoma
    • Ependymoma (< 12 months of age or metastatic disease at diagnosis)
    • Synchronous extraneural ATRT allowed
  • Meets criteria for 1 of the following risk groups:

    • Low-risk group:

      • Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity

        • Focal areas of anaplasia or other atypical features suggesting more aggressive phenotype in a tumor otherwise considered nodular desmoplastic should be treated on the intermediate-risk group, with final risk stratification at the discretion of principal investigator and study pathologist
      • No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF)

        • Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease when lumbar puncture is medically contraindicated
        • Intermediate-risk group assignment when there is no other evidence of metastasis and CSF sampling is not possible
      • Gross total resection, defined as residual tumor or imaging abnormality (not definitive for residual tumor) with a size of < 1 cm^2 confirmed on postoperative CT scan or MRI
      • Brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size < 1 cm^2) and otherwise meets criteria for the low-risk group, the patient will be classified as low-risk
    • Intermediate-risk group:

      • Histologically confirmed nodular desmoplastic medulloblastoma with less than gross total resection and no evidence of metastasis
      • Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no evidence of CNS metastasis
    • High-risk group:

      • Any eligible histologic diagnosis with evidence of CNS metastasis
      • Patients with extraneural metastasis are eligible for treatment on the high-risk group
  • Newly diagnosed disease

PATIENT CHARACTERISTICS:

  • Lansky performance status ≥ 30 (except for posterior fossa syndrome)
  • WBC > 2,000/mm^3
  • Platelets > 50,000/mm^3 (without support)
  • Hemoglobin > 8 g/dL (with or without support)
  • ANC > 500/mm^3
  • Serum creatinine < 3 times upper limit of normal (ULN)
  • ALT < 5 times ULN
  • Total bilirubin < 3 times ULN

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 31 days since prior definitive surgery
  • No prior radiotherapy or chemotherapy other than corticosteroid therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602667

Locations
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        
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Study Chair: Robert P. Sanders, MD St. Jude Children's Research Hospital
  More Information

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

Study ID Numbers: CDR0000580360, SJCRH-SJYC07
Study First Received: January 10, 2008
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00602667  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009