Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours
3 Years
18 Years
Both
Brain and Central Nervous System Tumors
Trial Information
Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours
OBJECTIVES:
Primary
- Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in
pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors.
Secondary
- Determine overall and relapse-free survival of patients treated with HART followed by
adjuvant combination chemotherapy comprising lomustine, cisplatin, and vincristine.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Radiotherapy: Patients undergo hyperfractionated accelerated radiotherapy (HART) twice
a day, 5 days a week, for 5 weeks.
- Adjuvant combination chemotherapy: Six weeks after the last radiotherapy dose, patients
receive oral lomustine once and cisplatin IV over 6 hours on day 1 and vincristine IV
on days 1, 8, and 15 . Treatment repeats every 6 weeks for 8 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5
years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment
Safety Issue:
Yes
Principal Investigator
Frank Saran, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000454540
NCT ID:
NCT00274911
Start Date:
February 2004
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- untreated childhood supratentorial primitive neuroectodermal tumor
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
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