A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy
A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour, etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.
Inclusion Criteria:
Histologically confirmed recurrent or refractory B-cell non-Hodgkin's lymphoma
o CD20 positive
Bidimensionally measurable or evaluable disease
19 years old and over
ECOG 0-2 or Karnofsky 70-100%
Life expectancy at least 3 months
WBC at least 3,000/mm3
Granulocyte count at least 1,000/mm3
Platelet count at least 100,000/mm3
Bilirubin no greater than 1.5 times upper limit of normal(ULN)
AST or ALT no greater than 2.5 times ULN
Creatinine no greater than 1.5 mg/dL
Fertile patients must use effective contraception
Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions (e.g., insulin for diabetes)
Exclusion Criteria: