At a glance
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Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
In Brief
A Phase 2 clinical trial evaluating carboplatin, etoposide, and 6 other interventions for Childhood Germ Cell Tumor and 2 related conditions. Completed, enrolled 23 participants across 1 site.
Detailed Summary
RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival. PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.
Study Details
Timeline
Interventions
Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes
600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3.
2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.
225 mg/m\^2 intravenous over 3 hours on Day -7.
150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4
Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg)
2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.
Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.