A Single-Center, Open-Label Study to Evaluate the Safety and Efficacy of Nipent, Cytoxan, and Rituxan ("PCR") in the Treatment of Previously Untreated and Treated, Stage III or IV, Low-Grade B-Cell Non-Hodgkin's Lymphoma or Bulky Lymphoma
All of the drugs [Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin)]
in this study are commonly used in the treatment of this cancer. However, using these drugs
in combination is investigational.
Before you can start treatment on this study, you will have what are called "screening
tests". These tests will help the doctor decide if you are eligible to take part in the
study. You will have a complete medical history and physical exam. You will have blood
collected (around 2-3 tablespoons) for routine tests. You will have a chest x-ray and CT
scans of the chest, abdomen (stomach), and pelvis (waist area). Tumors will be measured
using x-rays. You will have a sample of bone marrow collected. To collect a bone marrow
sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of
bone marrow is withdrawn through a large needle. If your doctor feels it is necessary, you
may also have lymph node biopsy samples taken for special tests. Women who are able to have
children must have a negative blood or urine pregnancy test.
During treatment you will be given a combination of three drugs in a 21 day (3 weeks) cycle.
All drugs will be given through a needle in a vein over 4-6 hours. You will receive
pentostatin first, then rituximab, and lastly cyclophosphamide. For each treatment cycle
cyclophosphamide, rituximab, and pentostatin will be given on Day 1, followed by 20 days of
During treatment, you will have around 2-3 tablespoons of blood collected at least once a
week for routine tests. You will also provide a urine sample for routine urine tests.
Depending on how the disease responds, treatment may be stopped after 3, 6, or 9 cycles.
You will be taken off treatment if your disease gets worse. If your treatment is delayed
for more than 2 weeks due to any side effect related to the treatment or for more than 3
weeks for any reason, you will be taken off of this study. If your doctor feels that you
are having serious or intolerable side effects that are not improved by standard supportive
care methods (such as medicine to control nausea or a transfusion to treat anemia) you will
be taken off of this study.
After Cycles 3, 6, and 9, tumors will be measured using x-rays or other scans (CT or MRI).
Bone marrow samples will be taken if they are needed to find out if the drug combination is
working to control your disease.
The maximum number of cycles that you can receive is 9. If you wish to continue using this
drug treatment, and it is beneficial to do so, you may continue to receive these drugs.
However, these drugs are commercially available, so you will be financially responsible
for the cost of these drugs.
After you receive the last cycle of chemotherapy, your doctor will decide your schedule of
follow-up exams. You will have follow-up exams every 3 months for one year, every 6 months
for 2nd year, then once after 1 year. During these exams, you will have a chest x-ray and CT
scans of the chest, abdomen (stomach), and pelvis (waist area). You will also have blood
collected (2-3 tablespoons) for routine tests.
This is an investigational study. All of the study drugs are approved by the FDA for cancer
treatment and are commercially available. However, the use of the drugs in combination is
investigational. Up to 100 patients will take part in this study. All enrolled will be at
M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Objective Response Rate (OR=CR+PR)
Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days).
Felipe Samaniego, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|