Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors
OBJECTIVES: I. Determine the complete response rate (chemotherapy complete response,
pathological complete response, or surgical complete response) to intensive chemotherapy
with autologous peripheral blood stem cell support in patients with cisplatin resistant germ
cell tumors. II. Determine duration of complete response and survival of these patients
after this therapy. III. Determine the toxic effects of this regimen in these patients. IV.
Determine the pharmacokinetics of this regimen and the relationship between these
pharmacokinetics, nature and duration of response to treatment, and the toxic effects in
these patients.
OUTLINE: This is an open label, multicenter study. Patients receive epirubicin IV over 15
minutes and paclitaxel IV over 3 hours on day 1, then filgrastim (G-CSF) subcutaneously (SQ)
on days 5-14. Peripheral blood stem cells (PBSC) are collected on days 13 and 14. This
course is repeated beginning on day 15. Patients then undergo a three part intensification
regimen. Part I: Patients receive cyclophosphamide IV and thiotepa IV by continuous infusion
on days 34 and 35. PBSC are reinfused on day 38, and G-CSF SQ is administered from day 39
until blood cell counts recover. Part II: Patients receive etoposide IV over 2 hours,
ifosfamide IV over 4 hours, and carboplatin IV over 6 hours on days 62-66. PBSC are
reinfused on day 70, and eventually G-CSF begins on day 71. Part III: Patients receive
etoposide, ifosfamide, and carboplatin on days 90-94 as in part II. PBSC are reinfused on
day 98 and eventually G-CSF begins on day 99. Patients are followed every month for the
first year, every 2 months for the second year, every 6 months for the third and fourth
years, then annually thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 2 years.
Interventional
Primary Purpose: Treatment
Pierre Biron, MD
Study Chair
Centre Leon Berard
United States: Federal Government
CDR0000067015
NCT00003852
March 1998
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