©2022 Stanford Medicine
S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma
Not Recruiting
Trial ID: NCT00006721
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from
dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either
kill them or deliver radioactive tumor-killing substances to them without harming normal
cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is
more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given
together with combination chemotherapy to see how well they work in treating patients with
newly-diagnosed non-Hodgkin's lymphoma.
Official Title
A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
Stanford Investigator(s)
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Harlan Pinto
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Eligibility
DISEASE CHARACTERISTICS:
- Histologically confirmed previously untreated bulky stage II or stage III or IV
follicular non-Hodgkin's lymphoma
- Grade I-III disease
- Cluster of differentiation antigen 20 (CD20) antigen positive
- Fewer than 5,000/mm^3 circulating lymphoid cells on a white blood cell (WBC)
differential count
- Bidimensionally measurable disease
- Bone marrow aspiration and biopsy within the past 42 days
- No clinical evidence of central nervous system (CNS) involvement by lymphoma
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
- Granulocyte count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No impaired cardiac status, including:
- Severe coronary artery disease
- Cardiomyopathy
- Congestive heart failure
- Serious arrhythmia
- Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan
(MUGA) or 2-D echocardiogram for questionable cardiac history
Other:
- No hypersensitivity to iodine
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after study
participation
- HIV negative
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior monoclonal antibodies for cancer
Chemotherapy:
- No prior chemotherapy for lymphoma
- Prior prednisone for non-lymphoma related illnesses allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for lymphoma
Surgery:
- See Disease Characteristics
Intervention(s):
drug: doxorubicin
drug: vincristine
radiation: tositumomab
drug: cyclophosphamide
drug: prednisone
biological: rituximab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061