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Phase II Study of CHOP/Rituxan Plus VELCADE in Mediastinal Large B-cell Lymphoma

Phase 2
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma

Thank you

Trial Information

Phase II Study of CHOP/Rituxan Plus VELCADE in Mediastinal Large B-cell Lymphoma

- This is a single arm phase 2 study of CHOP/Rituxan plus VELCADE followed by involved
field radiotherapy designed to evaluate the complete response to chemotherapy as
determined by PET scan following six cycles of therapy. One cycle equals 21 days.

- For each cycle, on Day 1, the patient will receive VELCADE intravenously, followed by
rituxan, and then followed by CHOP chemotherapy. Before receiving these drugs, the
patient will be given standard medications (Tylenol, Benadryl) to help minimize side
effects. They will also continue to take prednisone by mouth on days 2, 3, 4, and 5.
On Day 4, the patient will receive another dose of VELCADE.

- Before the beginning of every cycle of study treatment, the following will be
performed: Medical history; physical examination; and routine blood tests. After the
3rd and 6th cycle of study treatment, the patient will have tests to monitor the status
of their disease. These include PET scan, CT scans, and standard blood tests.

- After 6 cycles of chemotherapy, approximately 3 weeks of radiation therapy will begin.
One month after completing radiation therapy, the patient will return to the clinic for
a physical exam and blood tests. One month later, the following evaluations will
occur: PET and CT scans; medical history; physical exam; routine blood tests.

- There will be follow-up visits every 3 months for two years after the study treatment
is completed.

Inclusion Criteria:

- 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not part of normal medical care, with the understanding that consent may be withdrawn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 (ie, a hormonal contraceptive, intra-uterine
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.

- Histologic Documentation: Histologically confirmed Primary Mediastinal Large B-cell
Lymphoma with confirmatory immunoperoxidase stains including TRAF-1, and nuclear
c-rel. All cases must be reviewed at Brigham and Women's Hospital.

- Previously untreated patients with the exception of limited radiotherapy or steroids
for SVC syndrome

- Age > 18 years of age

- Measurable Disease defined as lesions that can be accurately measured in at least one
dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or
as ≥10 mm with spiral CT scan.

Exclusion Criteria:

- Patient has a platelet count of < 100,000/uL within 14 days before enrollment.

- Patient has an absolute neutrophil count of < 1500/uL within 14 days before

- Patient has a calculated or measured creatinine clearance of <30 mL/minute within 14
days before enrollment.

- Patient has ³Grade 2 peripheral neuropathy within 14 days before enrollment.

- Myocardial infarction within 6 months prior to enrollment or has New York Hospital
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 bortezomib, boron or mannitol.

- Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum b-human chorionic gonadotropin
(b-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 with 14 days before enrollment

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

- Patient has a cardiac ejection fraction < 50% by echocardiogram or MUGA scan

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the rate of complete response to therapy defined as resolution of PET avidity in all previously documented sites at the completion of chemotherapy.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ann LaCasce, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2006

Completion Date:

May 2008

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Dana Farber Cancer InstituteBoston, Massachusetts  02115