Trial Search Results

Study of Bexxar Combined With External Beam Radiation Therapy

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: GlaxoSmithKline

Intervention(s):

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

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

19 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lucy Schoen
6507251718
Not Recruiting