Dose Augmented Rituximab and ICE for Pts With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell NHL

Completed · Phase 2

Conditions studied: Lymphoma, B-cell Non-Hodgkin's Lymphoma

In brief

The purpose of this research is to study a treatment program for patients with aggressive lymphoma that has come back after initial or first therapy (called relapsed) or that has not responded to first therapy (called refractory). Since 1993, we have used a combination of chemotherapy known as ICE (Ifosfamide, Carboplatin, and Etoposide) for your type of lymphoma. In many patients, this treatment helps the disease to shrink before giving high-dose therapy and autologous stem cell transplant (ASCT). Only patients who respond to these types of treatments have a chance of their disease going away (remission) with an ASCT. In 1999, we studied the same treatment but added another medicine for your type of lymphoma, Rituximab (Rituxan), to the ICE treatment (RICE). More patients had lymphoma shrinkage from this treatment (chemosensitive disease) than with ICE alone. These patients then received high dose therapy and autologous stem cell transplant and have an improved chance of having a remission. ICE chemotherapy is standard chemotherapy used at Memorial Sloan-Kettering Cancer Center. However, it is different in this study because of the higher doses. We are testing higher doses of RICE treatment for patients in this study. In our current study in Hodgkin's lymphoma, we are giving these higher doses of ICE (called augmented ICE) to patients who also have higher risk. We hope to show in this study that by using Rituximab and augmented ICE that we can improve your ability to achieve a remission (that is, to have the disease go away).

Key facts

Study ID: NCT00588094
Run by: Memorial Sloan Kettering Cancer Center
People needed: 20
Starts: 2003-10-01
Expected to finish: 2010-03-01
Last updated by the study team: 2015-12-04

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologic diagnosis of the one of the following B cell aggressive lymphomas, confirmed by an MSKCC pathologist: Diffuse Large, Immunoblastic, Mantle cell, Anaplastic Large Cell, De novo transformation of follicular lymphoma, or classical Hodgkin's lymphoma which is CD20 antigen positive.
Tumors must stain positive for CD20.
Primary refractory disease proven by biopsy or fine needle aspiration (cytology) of an involved site
Relapsed diffuse large, immunoblastic, anaplastic, de novo transformation of follicular lymphoma, or classical Hodgkin's lymphoma which is CD20 antigen positive proven by biopsy or fine needle aspiration (cytology) of an involved field site and at least two of the three following risk factors: LDH> upper limit of normal, KPS < 80%, Stage III or IV disease.
All mantle cell lymphoma patients in first relapse
Failure of doxorubicin or mitoxantrone containing front-line therapy
Bidimensionally measurable disease.
Cardiac ejection fraction of greater than 50%, measured since last chemotherapy.
Serum creatinine <1.5 mg/dl; if creatinine >1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be >60 ml/minute.
ANC>1000/µl and Platelets>50,000/µl
Total bilirubin < 2.0 mg/dl in the absence of a history of Gilbert's disease.
Females of childbearing age must be on an acceptable form of birth control.
Age between 18 and 72
HIV I and II negative.
Patients or their guardians must be capable of providing informed consent.

You may not qualify if…

Any lymphoma subtype other than those described among the inclusion criteria.
All patients with relapsed diffuse large, immunoblastic, anaplastic, de novo transformation of follicular lymphoma, or classical Hodgkin's lymphoma which is CD20 antigen positive disease who have <2 of following risk factors: LDH> upper limit of normal, KPS < 80%, Stage III or IV disease.
History of second-line chemotherapy
Presence of CNS involvement.
Prior treatment with carboplatin, cisplatin, ifosfamide, or etoposide
Hepatitis B surface antigen positive.
Known pregnancy or breast-feeding.
Medical illness unrelated to NHL, which in the opinion of the attending physician and/or principal investigator will preclude administering chemotherapy safely.
History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix

Where it is running

Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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