Clinical trial

A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy

Name
0032-00-FB
Description
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.
Trial arms
Trial start
2000-09-01
Estimated PCD
2004-03-01
Trial end
2008-04-22
Status
Completed
Phase
Early phase I
Treatment
rituximab
Other names:
Rituxan
carboplatin
Other names:
Paraplatin
etoposide
Other names:
Etopophos, Toposar
ifosfamide
Other names:
Ifex
Size
-1
Eligibility criteria
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: * No myelodysplastic syndrome or chronic myeloid leukemia * Not pregnant or nursing/negative pregnancy test * No other prior malignancy except curatively treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix * No active serious infection * No other concurrent serious medical condition that would preclude study * No prior bone marrow or peripheral blood stem cell transplantation for non-Hodgkin's lymphoma * No other concurrent chemotherapy * No concurrent corticosteroids except transient administration as antiemetic * No concurrent radiotherapy * No other concurrent investigational therapy * No other concurrent antitumor agents
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'primaryPurpose': 'TREATMENT'}}
Updated at
2023-12-27

1 organization

4 drugs

1 indication

Indication
lymphoma