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Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bexxar
Acetaminophen
Diphenhydramine
Potassium Iodide (KI)
Sponsored by
Susan Knox
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bexxar + Total Body Irradiation (TBI)

Arm Description

Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).

Outcomes

Primary Outcome Measures

Clinical Response Rate
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 of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.
Overall Survival (OS) Rate
Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.

Full Information

First Posted
June 20, 2007
Last Updated
February 28, 2017
Sponsor
Susan Knox
Collaborators
Corixa Corporation, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00490009
Brief Title
Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
Official Title
Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan Knox
Collaborators
Corixa Corporation, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bexxar + Total Body Irradiation (TBI)
Arm Type
Experimental
Arm Description
Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
Intervention Type
Drug
Intervention Name(s)
Bexxar
Other Intervention Name(s)
Tositumomab, iodine-131 tositumomab, I-131 tositumomab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl
Intervention Description
As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions
Intervention Type
Drug
Intervention Name(s)
Potassium Iodide (KI)
Other Intervention Name(s)
Saturated solution potassium iodine (SSKI), Lugol's solution
Intervention Description
Administered to prevent thyroid blockage 130 mg orally 3 times a day,
Primary Outcome Measure Information:
Title
Clinical Response Rate
Description
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.
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Time to Progression (TTP)
Description
Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.
Time Frame
1.5 months; 3 months; 6 months; or Not Progressed
Title
Overall Survival (OS) Rate
Description
Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J Knox
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

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