Overview

Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
0
Participant gender:
All
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 them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to radiation therapy alone in treating patients with germ cell tumors in the brain.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Cancer and Leukaemia Group
Treatments:
Carboplatin
Etoposide
Etoposide phosphate
Ifosfamide
Criteria
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