High-Dose Doxorubicin and Ifosfamide Followed by Melphalan and Cisplatin for Patients With High-Risk and Recurrent Sarcoma
OBJECTIVES: I. Determine the feasibility of sequential high-dose chemotherapy with
ifosfamide and doxorubicin followed by melphalan and cisplatin, each followed by autologous
peripheral blood stem cell support, in patients with high-risk or advanced sarcomas. II.
Determine the toxic effects of this regimen in these patients. III. Determine response rate
and disease-free and overall survival in these patients treated with this regimen.
OUTLINE: Beginning at least 4 weeks prior to the start of chemotherapy, patients receive
filgrastim (G-CSF) subcutaneously daily until the completion of peripheral blood stem cell
(PBSC) harvesting. Beginning 5 days after the start of G-CSF, PBSCs are collected over
several days. Patients who do not mobilize sufficient cells undergo bone marrow harvest.
Regimen A: Patients receive high-dose ifosfamide IV and doxorubicin IV continuously over 96
hours on days -8 to -4. 12.5% of PBSCs or bone marrow are reinfused on day -2 and 37.5% are
reinfused on day 0. Patients receive G-CSF IV beginning on day 0 and continuing until blood
counts recover. Regimen B: Beginning at least 4 weeks after day 1 of Regimen A, patients
receive high-dose melphalan IV followed immediately by cisplatin IV on days -11 and -4.
Patients receive G-CSF IV on days -10 to -6. 12.5% of PBSCs or bone marrow are reinfused on
day -3 and the remaining 37.5% are reinfused on day 0. Patients receive G-CSF IV beginning
on day 0 and continuing until blood counts recover. Patients are followed monthly for 1
year, every 3 months for 1 year, and then as needed for 3 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the feasibility of administration of two cycles of high-dose chemotherapy followed by autologous stem cell support in patients with high-risk or advanced sarcomas.
2 years after completion of treatment
George Somlo, MD
Beckman Research Institute
United States: Federal Government
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|