Study of Bexxar Combined With External Beam Radiation Therapy

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Iodine; Iodine-131 anti-B1 antibody; Lugol's solution; Pharmaceutical Solutions

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