At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed germ cell tumor (GCT) with pathology review at the center
- ✓Advanced GCT with measurable/evaluable disease, elevated serum tumor markers (AFP/HCG), or known residual disease after post-chemotherapy surgery
- ✓Established clinical resistance to cisplatin, defined as failure to achieve durable complete response to a cisplatin-based regimen
- ✓One or more unfavorable prognostic factors: extragonadal primary site, testis/ovarian primary with best response of incomplete response to first-line therapy, or partial response with normal tumor markers lasting ≤6 months, or prior ifosfamide-containing therapy
- ✕Active infection at time of enrollment
- ✕Concurrent treatment with chemotherapy
- ✕Inability to comply with treatment protocol or specified follow-up safety/effectiveness testing
- ✕Prior high-dose therapy with autologous bone marrow transplantation (AuBMT)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PHASE I/II TRIAL OF SEQUENTIAL TAXOL/IFOSFAMIDE AND DOSEINTENSIVE CARBOPLATIN/ETOPOSIDE WITH STEM CELL SUPPORT IN CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH UNFAVORABLE PROGNOSTIC FEATURES
In Brief
A Phase 2 clinical trial evaluating filgrastim, carboplatin, and 4 other interventions for Extragonadal Germ Cell Tumor and 2 related conditions. Completed, enrolled 108 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, carboplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing them or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more tumor cells are killed. The design of this trial is a phase I/II trial of sequential accelerated chemotherapy cycles with taxol/ifosfamide and carboplatin/etoposide administered with G-CSF and PBSC support. PURPOSE: The purpose of this study is to determine the effects of an intensive sequence of chemotherapy drugs in patients with metastatic germ cell cancer. All of these chemotherapy drugs are known to be active in this disease.