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
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Harlan Pinto
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

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