This phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu
Principal Investigator
Anne-Marie Langevin
Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu
| Arm | Description | Intervention |
|---|---|---|
Arm III (bleomycin, etoposide, carboplatin) | Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Given IV Other names:
Given IV Other names:
Correlative studies Ancillary studies Other names:
Given IV Other names:
Given IV Other names:
Correlative studies Other names:
Ancillary studies |
Low-Risk (observation) | Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. | Correlative studies Ancillary studies Other names:
Undergo observation Other names:
Correlative studies Other names:
Ancillary studies |
Arm II (bleomycin, etoposide, cisplatin) | Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Given IV Other names:
Correlative studies Ancillary studies Other names:
Given IV Other names:
Given IV Other names:
Given IV Other names:
Correlative studies Other names:
Ancillary studies |
Arm I (bleomycin, carboplatin, etoposide) | Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Given IV Other names:
Given IV Other names:
Correlative studies Ancillary studies Other names:
Given IV Other names:
Given IV Other names:
Correlative studies Other names:
Ancillary studies |
Arm IV (bleomycin, etoposide, cisplatin) | Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Given IV Other names:
Correlative studies Ancillary studies Other names:
Given IV Other names:
Given IV Other names:
Given IV Other names:
Correlative studies Other names:
Ancillary studies |