Status:
COMPLETED
Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, ifosfamide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping t...
Detailed Description
OBJECTIVES: Primary * Evaluate and compare, in a non-randomized protocol, reduced-dose craniospinal radiotherapy alone or combination chemotherapy comprising carboplatin, etoposide phosphate, and if...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Clinical and radiological evidence of intracranial germ cell tumor, classified as 1 of the following:
- Germinoma
- Pure germinoma
- Germinoma with mature and/or immature teratoma
- Secreting germ cell tumor
- Elevated tumor markers in serum and/or cerebral spinal fluid as evidenced by any of the following:
- Alpha-fetoprotein \> 25 ng/mL
- β-human choriogonadotropin \> 50 IU/L
- Any tumor containing 1 of these components:
- Yolk sac tumor
- Choriocarcinoma
- Embryonal tumor
- Normal tumor markers allowed
- Diagnosis confirmed by histology or elevated serum markers
- Metastatic or nonmetastatic disease
- Two separate tumors in the suprasellar and pineal areas without evidence of metastatic disease elsewhere are considered nonmetastatic multifocal disease
- Study treatment must begin ≤ 4 weeks after diagnosis
- No pure immature or mature teratomas
- The following additional patients are eligible:
- Patients who are \> 18 years of age provided no other appropriate protocol exists
- Patients who were diagnosed \> 4 weeks ago
- Patients who are in relapse
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- No prior treatment except surgery
- No concurrent amino glycosides or other nephrotoxic drugs during ifosfamide administration
- No concurrent growth factors
- No other concurrent chemotherapy or radiotherapy
Exclusion
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00293358
Start Date
January 1 1997
End Date
December 1 2006
Last Update
September 17 2013
Active Locations (21)
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1
Our Lady's Hospital for Sick Children
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 at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ