Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Lymphoma, Non-Hodgkin

Treatments: Procedure: External beam radiotherapy (XRT); Drug: Bexxar (tositumomab); Drug: Potassium Iodide (KI)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00490490

IRB-07479

LYMNHL0046 (Other Identifier)

97437 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).

Full description

Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam

Enrollment: 8 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

• Histologically confirmed low grade CD20+ B cell non-Hodgkin lymphoma (NHL) patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm.
• The patients must have failed at least one chemotherapy regimen
• No anticancer treatment for three weeks prior to study initiation (six weeks if Rituximab, nitrosourea or Mitomycin C)
• Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
• An institutional review board- (IRB)-approved signed informed consent
• Age 19 years or older
• Expected survival of at least 6 months
• Prestudy Performance Status of 0, 1 or 2 according to the World Health Organization (WHO)
• Absolute neutrophil count (ANC) of at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hct > 30%
• Hgb > 9.0 gm
• Bilirubin ≤ 2.0
• Creatinine ≤ 2.0
• Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment
• Acceptable birth control method for men and women

EXCLUSION CRITERIA

• Disease progression within 3 months of last chemotherapy
• Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
• Platelet count less than 100,000/mm³
• Hypocellular bone marrow (≤ 15% cellularity)
• Marked reduction in bone marrow precursors of one or more cell lines
• History of failed stem cell collection
• Prior treatment with fludarabine
• Prior radioimmunotherapy
• Presence of central nervous system (CNS) lymphoma
• HIV or AIDS-related lymphoma
• Evidence of myelodysplasia on bone marrow biopsy
• Abnormal bone marrow cytogenetics
• Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
• Patients who have received filgrastim
• Sargramostim therapy within 3 weeks prior to treatment
• Presence of human anti-mouse antibody (HAMA) reactivity in patients with prior exposure to murine antibodies or proteins
• Serious nonmalignant disease or infection, which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives
• Another primary malignancy (other than squamous cell and basal cell cancer of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate-specific antigen, PSA) for which the patients has not been disease free for at least 3 years
• Major surgery, other than diagnostic surgery within 4 weeks
• Pleural effusion
• Pregnant
• Lactating

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Tositumomab + XRT + KI

Experimental group

Description:

Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Treatment:

Drug: Potassium Iodide (KI)

Drug: Bexxar (tositumomab)

Procedure: External beam radiotherapy (XRT)