Dose Augmented Rituximab and ICE for Pts With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell NHL
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 4/21/2016 |
| Start Date: | October 2003 |
| End Date: | March 2010 |
A Phase II Study of Dose Augmented Rituximab and Ice for Patients With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell Non-Hodgkin's Lymphoma Undergoing Second-Line Therapy Prior to Stem Cell Transplantation
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).
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).
The purpose of this study is to determine if dose escalation of the rituximab-ICE (RICEesc)
program can improve the overall response rate of patients with primary refractory or poor
risk relapsed aggressive B cell lymphoma. R-ICEesc will be administered for 2 cycles with
peripheral blood progenitor cells (PBPCs) collected after cycle 2.
A two-stage design will be employed, such that the study will be terminated if in the first
cohort of patients it appears that the overall response rate is <50% or if >25% patients
fail to mobilize at least 2 x 106 CD34+ cells/kg.
program can improve the overall response rate of patients with primary refractory or poor
risk relapsed aggressive B cell lymphoma. R-ICEesc will be administered for 2 cycles with
peripheral blood progenitor cells (PBPCs) collected after cycle 2.
A two-stage design will be employed, such that the study will be terminated if in the first
cohort of patients it appears that the overall response rate is <50% or if >25% patients
fail to mobilize at least 2 x 106 CD34+ cells/kg.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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