Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy
Stopped early · Phase 2
Conditions studied: Lymphoma, Non-Hodgkin
In brief
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).
Key facts
- Study ID
- NCT00490490
- Run by
- Stanford University
- People needed
- 8
- Starts
- 2007-01-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2017-03-29
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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