Overview

Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma

Status:
Terminated
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
Summary
This phase II trial is studying how well giving rituximab together with combination chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining a monoclonal antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more cancer cells.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Antibodies, Monoclonal
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Criteria
Inclusion Criteria:

- Patients must have histologically confirmed diagnosis of diffuse large cell lymphoma

- Patients must be stage I or II (Modified Ann Arbor staging)

- Baseline measurements and evaluations must be obtained within 4 weeks of registration
to the study; abnormal PET scans will not constitute evaluable disease unless verified
by CT scan or other appropriate imaging; patients must have at least one objective
measurable disease parameter (a lesion with at least 1 dimension > 1.5 cm); or if they
are stage 1

- Stage I patients must have at least one of the following risk factors:

- Age >= 60 years

- Bulky disease (>= 5 cm in at least one dimension)

- Elevated Lactate Dehydrogenase (LDH) above institutional upper limit of normal

- Eastern Cooperative Oncology Group (ECOG) performance status = 2

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Absolute neutrophil count >= 1500/mm^3 (includes neutrophils and bands)

- Platelet count >= 100,000/mm^3

- Creatinine < 2.0 mg/dl

- Total bilirubin < 2 mg/dl (may be up to 3.0 mg/dl if due to liver involvement by
lymphoma); patients with elevated total bilirubin should have a direct bilirubin
checked; if the direct bilirubin is normal there is no need for a dose reduction

- Patients must have left ventricular ejection fraction (LVEF) of > 45%

- Patients must be tested for hepatitis B (HBV) surface antigen within 2 weeks of
registration

- NOTE: Patients who test positive will be allowed to participate but must be
followed closely for clinical and laboratory signs of active HBV infection and
for signs of hepatitis

Exclusion Criteria:

- Prior chemotherapy, radiation therapy, radioimmunotherapy, or immunotherapy; a short
course (=< 14 days prior to registration) of corticosteroids is allowed

- Evidence of other malignancy:

- Prior chemotherapy or prior radiation therapy for other malignancies

- Currently receiving hormone therapy or chemotherapy for another malignancy even
if the treatment is being provided in the adjuvant treatment setting, i.e. with
no evidence of the original other malignancy

- Adjuvant hormonal therapy must have been discontinued > 3 months before entering
this study

- Patients are eligible if they meet the following conditions: (a) treated
carcinoma-in-situ of the cervix; (b) treated squamous cell or basal cell skin
cancer; or (c) any other surgically cured malignancy from which the patient has
been disease free for at least 3 years

- Pregnant or breast feeding, as there would be radiation exposure to the fetus or
child; a negative pregnancy test is required =< 1 week prior to registration for women
of childbearing potential (WOCBP). Women of childbearing potential and sexually active
males must be strongly advised to use an accepted and effective method of
contraception

- Known central nervous system (CNS) lymphoma, testicular lymphoma, or vitreous lymphoma

- Known HIV infection. The safety of Zevalin™ in this population has not been tested at
this time

- Serious coexisting medical condition or active infection which would compromise the
ability to deliver standard R-CHOP chemotherapy

- Evidence of myelodysplasia on bone marrow aspiration and biopsy