Clinical Trial · NCT01389076

Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma

Overview

Patients with a type of non-Hodgkin lymphoma, called follicular lymphoma and have not yet had previous systemic treatment, such as chemotherapy or immunotherapy will be invited to participate. This research study is being conducted in order to evaluate the combination of lowdose methotrexate and Iodine I 131 tositumomab (Bexxar) with regards to whether the combination will reduce the occurrence of the HAMA (Human Anti-Mouse Antibody) response. HAMA is an immune reaction against the tositumomab protein. Symptoms arising from HAMA can range from a mild form, like a rash, to a more extreme and possibly life-threatening level. HAMA can also decrease the effectiveness of the treatment, or create a future reaction if a patient is given another treatment containing mouse antibodies. In addition to evaluating the occurrence of HAMA, this research study will also look at the short and long-term effectiveness of this combination in the treatment of lymphoma, as well as its safety.

Sponsor

University of Michigan Rogel Cancer Center

Phase

Phase 2

Contacts

Mark Kaminski, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01389076

Drug / Compound

tositumomab

Isotope(s):

Target(s):

cd20

Ligand Class: Antibodies

Eligibility

Inclusion

Patients must have adequate renal function (defined as serum creatinine \<2.0) and hepatic function (defined as total bilirubin \<1.5 x ULN and Aspartate Aminotransferase (AST) \<3 x ULN) within 14 days of study entry.
Patients must have a willingness and ability to follow prescribed radiation precautions
Patients must have a histologically-confirmed diagnosis of follicular non-Hodgkin's B-cell lymphoma, grade 1-2 (grade 1 or grade 2 by WHO classification prior to 2009).
Patients must have Ann Arbor Stage III or IV extent of disease after complete staging.
Patients must have a performance status of 0-2 on the Eastern Cancer Oncology Group (ECOG) scale and an anticipated survival of at least 3 months.
Patients must have an absolute neutrophil count \>1500 cells/mm3 and a platelet count \>100,000 cells/mm3 within 14 days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
Patients must have bi-dimensionally measurable disease.
Patients must not have had any previous treatment for low-grade lymphoma including chemotherapy or radiation. They may be newly diagnosed or observed without treatment after diagnosis. Symptomatic and asymptomatic patients will be eligible.

Exclusion

Patients with active obstructive hydronephrosis.
Patients with New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
Patients with evidence of active infection requiring IV antibiotics at the time of study entry.
Patients with previous allergic reactions to methotrexate.
Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
Patients with known brain or leptomeningeal metastases.
Patients with previous allergic reactions to iodine. This does not include reacting to IV iodine-containing contrast materials.
Patients with known HIV infection.
Detectable serum levels of HAMA.
Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
Patients who are pregnant or nursing. Patients of childbearing potential must undergo a pregnancy test within 7 days of study entry and methotrexate is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy.
Patients who were previously given any monoclonal antibody, regardless of species, for any condition.
Patients with follicular Grade 3a or 3b by WHO Classification.