At a glance
ClinicalIndex Comparison Record- ✓Evaluable germ cell cancer not curable by standard salvage therapy or viable cancer on resection of post-chemotherapy residual masses in intermediate or high risk category
- ✓Bidimensionally measurable disease with measurements within 21 days of study entry
- ✓Tumor markers (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic gonadotropin) studies within 7 days prior to study entry
- ✓Age 16 and over
- ✕No prior bone marrow or stem cell rescue with high-dose chemotherapy
- ✕No prior paclitaxel
- ✕HIV positive
- ✕Prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
In Brief
A Phase 2 clinical trial evaluating filgrastim, carboplatin, and 5 other interventions for Brain and Central Nervous System Tumors and 4 related conditions. Completed, enrolled 48 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.
Study Details
Timeline
Interventions
5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.
AUC=7, daily X 3
20 mg/kg by 2 hours infusion daily X 3
3 gm/m2 IV over 30 minutes X 3 days
425 mg/m2 as 24 hour continuous infusion
Given in two divided infusions on day -2 and day 0
Two cycles of high dose chemotherapy followed by stem cell reinfusion