Trial Search Results

Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Susan Knox

Collaborator: GlaxoSmithKline

Stanford Investigator(s):

Intervention(s):

  • Drug: Bexxar
  • Drug: Acetaminophen
  • Drug: Diphenhydramine
  • Drug: Potassium Iodide (KI)

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Histologically-confirmed, diffuse large cell lymphoma (DLCL), CD20+ B-cell non-Hodgkin
   lymphoma (NHL) who have relapsed after chemotherapy or are chemotherapy resistant,
   without prior history of low grade NHL. The patient must have failed at least one
   chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.

   - No anticancer treatment for three weeks prior to the treatment dose of Bexxar (6 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

   - Prestudy Karnofsky Performance Status of ≥ 70%

   - Absolute neutrophil count (ANC) ≥ 1,500/mm³

   - Platelet count ≥ 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

   - Female patients who are not pregnant

   - Not lactating

Exclusion Criteria:

   - Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell
   rescue

   - Platelet count < 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

   - Patients with known HIV or AIDS-related lymphoma

   - Patients with evidence of myelodysplasia on bone marrow biopsy

   - Patients who have received prior external beam radiation therapy to more than 25% of
   active bone marrow

   - Patients who have received filgrastim or sargramostim therapy within 3 weeks prior to
   treatment

   - Pregnant

   - Lactating

   - 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,
   would compromise other protocol objectives

   - Another primary malignancy (other than squamous cell and basal cell carcinoma of the
   skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate
   specific antigen levels) for which the patients has not been disease-free for at least
   3 years

   - Major surgery, other than diagnostic surgery, within 4 weeks

   - Patients with pleural effusion

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