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Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

This study has been completed.
Sponsor:
Collaborators:
Corixa Corporation
GlaxoSmithKline
Information provided by (Responsible Party):
Susan Knox, Stanford University
ClinicalTrials.gov Identifier:
NCT00490009
First received: June 20, 2007
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Lymphoma Drug: Bexxar Drug: Acetaminophen Drug: Diphenhydramine Drug: Potassium Iodide (KI) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)

Resource links provided by NLM:


Further study details as provided by Susan Knox, Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 9
Study Start Date: September 2004
Study Completion Date: June 2013
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bexxar + Total Body Irradiation (TBI)
Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490009

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Susan Knox
Corixa Corporation
GlaxoSmithKline
Investigators
Principal Investigator: Susan J Knox Stanford University
  More Information

Responsible Party: Susan Knox, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00490009     History of Changes
Other Study ID Numbers: IRB-10275
LYMNHL0019 ( Other Identifier: OnCore )
30978 ( Other Identifier: Stanford SPO )
Study First Received: June 20, 2007
Results First Received: January 9, 2017
Last Updated: February 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pharmaceutical Solutions
Acetaminophen
Diphenhydramine
Lugol's solution
Promethazine
Iodine-131 anti-B1 antibody
Iodine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Hemostatics
Coagulants
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on June 22, 2017