Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

NCT ID: NCT00490009

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2013-06-30

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bexxar + Total Body Irradiation (TBI)

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

Group Type: EXPERIMENTAL

Bexxar

Intervention Type: DRUG

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

Acetaminophen

Intervention Type: DRUG

As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain

Diphenhydramine

Intervention Type: DRUG

As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions

Potassium Iodide (KI)

Intervention Type: DRUG

Administered to prevent thyroid blockage 130 mg orally 3 times a day,

Interventions

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

Intervention Type: DRUG

Acetaminophen

As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain

Intervention Type: DRUG

Diphenhydramine

As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions

Intervention Type: DRUG

Potassium Iodide (KI)

Administered to prevent thyroid blockage 130 mg orally 3 times a day,

Intervention Type: DRUG

Other Intervention Names

Tositumomab; iodine-131 tositumomab; I-131 tositumomab; Tylenol; Benadryl; Saturated solution potassium iodine (SSKI); Lugol's solution

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corixa Corporation

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Susan Knox

OTHER

Sponsor Role: lead

Responsible Party

Susan Knox

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susan J Knox

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

LYMNHL0019

Identifier Type: OTHER

Identifier Source: secondary_id

30978

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-10275

Identifier Type: -

Identifier Source: org_study_id