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Phase II Trial of "VIPER" Chemotherapy in Relapsed and Refractory Diffuse Large B-cell Lymphoma (NHL)

Phase 2
18 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

Phase II Trial of "VIPER" Chemotherapy in Relapsed and Refractory Diffuse Large B-cell Lymphoma (NHL)

Single arm phase II trial of combination therapy bortezomib, DICE, and Rituximab in patients
with relapsed and refractory diffuse large B-cell non-Hodgkin's lymphoma (NHL)

VIPER chemotherapy will be administered every 28 days at the following doses:

- Dexamethasone 40 mg IV days 1-4

- Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4

- Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)

- Cisplatin 25 mg IV days 1-4

- Etoposide 100 mg/m2 CIVI over 24 hours days 1-4

- Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)

- VELCADE 1.5 mg/m2 on days 2 and 5

Inclusion Criteria:

- Histologically confirmed diagnosis of CD20 positive, diffuse large B-cell NHL; de
novo or transformed histologies are acceptable

- Patient must have relapsed after or not responded to at least one standard, upfront
multi-agent chemotherapy for DLBCL

- Measurable PET positive disease, as defined by tumor mass > 1.5 cm in one dimension

- Stage II, III, or IV disease

- Age > 18 years

- Adequate liver and kidney function (total bilirubin < 2 x ULN and creatinine < 2.0
mg/dl, unless abnormalities are related to lymphoma or Gilbert's disease

- Adequate bone marrow reserves (absolute neutrophil count >1500 cells/mm3 and platelet
count > 100,000, unless cytopenias are the result of marrow infiltration by lymphoma

- ECOG performance status < 2

- Life expectancy of at least 3 months

- Bortezomib-naive

- Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

- Male subject agrees to use an acceptable method for contraception for the duration of
the study.

Exclusion Criteria:

- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.

- Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled
angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
of acute ischemia or active conduction system abnormalities. Prior to study entry,
any ECG abnormality at Screening has to be documented by the investigator as not
medically relevant.

- Patient has hypersensitivity to boron or mannitol

- Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum β-human chorionic gonadotropin
(β-hCG) pregnancy test result obtained during screening. (Pregnancy testing is not
required for post-menopausal or surgically sterilized women)

- Patient has received other investigational drugs or cytotoxic chemotherapy within 14
days of enrollment

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study

- Known HIV infection

- Active Hepatitis B or C as defined by positive Hepatitis B surface antigen or
hepatitis C RNA

- Known CNS disease

- Pregnant or nursing women

- Concurrent treatment with other chemotherapy or anti-lymphoma therapy, including
corticosteroids, unless on a stable dose of corticosteroids less than the equivalent
of 20 mg of prednisone each day for treatment of disease not related to lymphoma

- Concomitant malignancies or previous malignancies within the last five years, with
the exception of adequately treated basal or squamous cell carcinoma of the skin or
carcinoma in situ of the cervix.

- Any condition that, in the opinion of the investigator, would prevent the subject
from being fully compliant with the protocol.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determine rate of response to chemotherapy

Outcome Time Frame:

duration of study

Safety Issue:


Principal Investigator

Richard Furman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

December 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • diffuse large b cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse



Weill Cornell Medical College New York, New York  10021