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Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490009
First Posted: June 22, 2007
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Corixa Corporation
GlaxoSmithKline
Information provided by (Responsible Party):
Susan Knox, Stanford University
June 20, 2007
June 22, 2007
January 9, 2017
February 28, 2017
March 30, 2017
September 2004
April 2010   (Final data collection date for primary outcome measure)
Clinical Response Rate [ Time Frame: 6 years ]
Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
Response rate and duration of response [ Time Frame: Following treatment ]
Complete list of historical versions of study NCT00490009 on ClinicalTrials.gov Archive Site
  • Time to Progression (TTP) [ Time Frame: 1.5 months; 3 months; 6 months; or Not Progressed ]
    Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.
  • Overall Survival (OS) Rate [ Time Frame: 6 years ]
    Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.
Time to Progression (TTP), Overall Survival, HAMA incidence, safety and tolerance (including collection of data on late effects) [ Time Frame: Following treatment ]
Not Provided
Not Provided
 
Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (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).

There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population.

This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
  • Drug: Bexxar

    Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells.

    Bexxar will be administered to provide the following patient-specific radiotherapy:

    • Platelet count of 150,000/mm³ = 75 cGy
    • Platelet count ≥ 100,000/mm³ but < 150,000/mm³ = 65 cGy
    Other Names:
    • Tositumomab
    • iodine-131 tositumomab
    • I-131 tositumomab
  • Drug: Acetaminophen
    As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain
    Other Name: Tylenol
  • Drug: Diphenhydramine
    As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions
    Other Name: Benadryl
  • Drug: Potassium Iodide (KI)
    Administered to prevent thyroid blockage 130 mg orally 3 times a day,
    Other Names:
    • Saturated solution potassium iodine (SSKI)
    • Lugol's solution
Experimental: Bexxar + Total Body Irradiation (TBI)
Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
Interventions:
  • Drug: Bexxar
  • Drug: Acetaminophen
  • Drug: Diphenhydramine
  • Drug: Potassium Iodide (KI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
June 2013
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00490009
IRB-10275
LYMNHL0019 ( Other Identifier: OnCore )
30978 ( Other Identifier: Stanford SPO )
Yes
Not Provided
Plan to Share IPD: No
Susan Knox, Stanford University
Susan Knox
  • Corixa Corporation
  • GlaxoSmithKline
Principal Investigator: Susan J Knox Stanford University
Stanford University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP