Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

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Micronutrients

Anti-Infective Agents

Hematinics

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Antibodies

Antibodies, Monoclonal

Methotrexate

Immunoglobulins

Iodine

Cadexomer iodine

Folic Acid Antagonists

Tositumomab I-131

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Immunosuppressive Agents

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

Iodine I 131 tositumomab (Bexxar) is a radioimmunotherapy (RIT) drug. RIT is a treatment strategy designed to target radiation specifically to cancer cells by attaching a radioactive atom to a monoclonal antibody, an immune system protein that binds to a particular protein. The Iodine I 131 tositumomab (Bexxar) therapeutic regimen is delivered in two sets of intravenous infusions given about 7 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body.

Bexxar

Methotrexate is an antifolate drug. It interferes with cells' ability to copy their DNA. This mainly affects cells that are dividing frequently, such as immune system cells and cancer cells. Methotrexate will be used in this study to try to prevent the occurrence of HAMA by limiting your body's ability to produce anti mouse antibodies.

Low Dose Methotrexate

Mark Kaminski, M.D.

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.

This is a single-arm, single institution, Phase II study to test the use of low-dose methotrexate in combination with I-131 tositumomab for its ability to lower the rate of (human anti-mouse antibody) HAMA formation in patients with previously untreated low-grade follicular lymphoma. Low-dose methotrexate will be given beginning 3 weeks prior to the first infusion of I-131 tositumomab (4 weekly doses) and continued for 6 weeks (10 total doses), the period of time during which the development of HAMA is most detrimental. A total of 61 patients will be enrolled. The primary endpoint of the study is the determination of the rate of HAMA conversion within the first seven weeks following treatment. The secondary endpoints include response rates, progression-free and overall survival, and safety.

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

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

The percentage of patients that experience early onset HAMA conversion following treatment. Early-onset HAMA is defined as antimouse antibody levels (in blood serum) of at least 5 times the level of detection, occurring at or prior to the 7th week of I-131 tositumomab therapy.

The overall response rate (PR \[partial response\] + CR \[complete response\]) was determined.

Partial response is defined as the regression of measurable disease with no new sites of disease.

Complete response is defined as the disappearance of all evidence of disease.

The median time patients survived without progression.

GlaxoSmithKline

University of Michigan Rogel Cancer Center

Low dose methotrexate and Bexxar (tositumomab)

Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.

On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab).

Methotrexate and Bexxar

Age, Continuous

Gender

This trial was abandoned prematurely due to the withdrawal of Bexxar by the manufacturer and failure to find another supplier.

Dr. Mark Kaminski, M.D.

Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment

Percentage of Participants That Respond to Treatment

The Percentage of Participants Alive at 2 Years

Due to the withdrawal of Bexxar by the manufacture and failure to find another supplier, the trial was abandoned and follow-up scans were not obtained. Therefore only survival is known. Progression information is not available.

Median Progression Free Survival (PFS) Time

Number of Participants That Experienced SAEs During Treatment.

Overall Study

Spots Global Cancer Trial Database for low dose methotrexate