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Status:

UNKNOWN

Radiation Therapy Followed By Combination Chemotherapy in Treating Young Patients With Supratentorial Primitive Neuroectodermal Tumors

Lead Sponsor:

Children's Cancer and Leukaemia Group

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

3-18 years

Phase:

PHASE2

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, cisplatin, and vincristine, work in different ways to stop the growth of tumor ...

Detailed Description

OBJECTIVES: Primary * Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors. Secondary * ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically proven nonpineal supratentorial primitive neuroectodermal tumors
  • No supratentorial atypical teratoid/rhabdoid tumors or medulloepitheliomas
  • Localized or metastatic disease
  • Metastatic disease is defined as unequivocal evidence of supratentorial metastases and/or spinal metastases on pre-operative or postoperative MRI scan OR tumor cells seen on cytospin analysis of lumbar cerebrospinal fluid (stage M1) performed between 15 days and 21 days after surgery
  • Has undergone surgical resection within the past 4-6 weeks
  • PATIENT CHARACTERISTICS:
  • Able to cooperate with twice daily fractions of radiotherapy
  • Hemoglobin ≥ 10 g/dL
  • Absolute neutrophil count ≥ 1,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Neurologically stable (or improving) during the week before starting radiotherapy
  • Lansky performance status 30-100% (for patients 1 to 16 years of age) OR
  • Karnofsky performance status 30-100% (for patients over 16 years of age)
  • Must be able to comply with the chemotherapy protocol (e.g., no hearing loss, renal impairment)
  • No presence of active uncontrolled infection
  • No previous malignant disease
  • Not pregnant or nursing
  • No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility
  • PRIOR CONCURRENT THERAPY:
  • No previous chemotherapy or radiotherapy
  • The patient should not be receiving steroids, if possible, at the start of radiotherapy or should be on a stable or reducing dose of steroids during the week before starting radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    February 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00274911

    Start Date

    February 1 2004

    Last Update

    August 2 2013

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    Our Lady's Hospital for Sick Children Crumlin

    Dublin, Ireland, 12

    2

    Birmingham Children's Hospital

    Birmingham, England, United Kingdom, B4 6NH

    3

    Institute of Child Health at University of Bristol

    Bristol, England, United Kingdom, BS2 8AE

    4

    Addenbrooke's Hospital

    Cambridge, England, United Kingdom, CB2 2QQ