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Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

Primary Purpose

Lymphoma, Non-Hodgkin

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bexxar (tositumomab)

External beam radiotherapy (XRT)

Potassium Iodide (KI)

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

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

INCLUSION CRITERIA

Histologically confirmed low grade CD20+ B cell non-Hodgkin lymphoma (NHL) patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm.
The patients must have failed at least one chemotherapy regimen
No anticancer treatment for three weeks prior to study initiation (six 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
Expected survival of at least 6 months
Prestudy Performance Status of 0, 1 or 2 according to the World Health Organization (WHO)
Absolute neutrophil count (ANC) of at least 1,500/mm³
Platelet count at least 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

EXCLUSION CRITERIA

Disease progression within 3 months of last chemotherapy
Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
Platelet count less than 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
HIV or AIDS-related lymphoma
Evidence of myelodysplasia on bone marrow biopsy
Abnormal bone marrow cytogenetics
Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
Patients who have received filgrastim
Sargramostim therapy within 3 weeks prior to treatment
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 and/or sponsor, would compromise other protocol objectives
Another primary malignancy (other than squamous cell and basal cell cancer of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate-specific antigen, PSA) for which the patients has not been disease free for at least 3 years
Major surgery, other than diagnostic surgery within 4 weeks
Pleural effusion
Pregnant
Lactating

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tositumomab + XRT + KI

Arm Description

Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Outcomes

Primary Outcome Measures

Complete Response (CR) Rate

Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR No evidence of disease and symptoms Any macroscopic nodules detected in any organs no longer present. Any palpable lymph node is normal and greatest diameter is < 1.0 cm. The enlarged organs decreased in size and not palpable The bone marrow biopsy and aspirate are negative for disease Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria No evidence of disease and symptoms Any lymph node mass > 1.0 cm^2 diameter has regressed is size by more than 75%. No macroscopic nodules in any organs Any palpable lymph node is normal and greatest diameter is < 1.0 cm. The bone marrow biopsy and aspirate are negative for disease The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia

Secondary Outcome Measures

Overall Response Rate (ORR)

ORR is assessed as the sum of the overall rates of CR confirmed by positron emission tomography (PET) CR not confirmed by PET, and Partial response (PR) negative for progression by PET

Time-to-Progression (TTP)

Full Information

NCT ID

NCT00490490

First Posted

June 20, 2007

Last Updated

February 9, 2017

Sponsor

Stanford University

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00490490

Brief Title

Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

Official Title

Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Low Accrual

Study Start Date

January 2007 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).

Detailed Description

Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam

6. Conditions and Keywords

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

Lymphoma, Non-Hodgkin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tositumomab + XRT + KI

Arm Type

Experimental

Arm Description

Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Intervention Type

Drug

Intervention Name(s)

Bexxar (tositumomab)

Other Intervention Name(s)

131-iodine tositumomab

Intervention Description

Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy.

Intervention Type

Procedure

Intervention Name(s)

External beam radiotherapy (XRT)

Other Intervention Name(s)

Radiotherapy (RT)

Intervention Description

Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study.

Intervention Type

Drug

Intervention Name(s)

Potassium Iodide (KI)

Other Intervention Name(s)

Saturated Solution Potassium Iodide (SSKI), Lugol's solution, Potassium iodide tablets

Intervention Description

Potassium iodide (KI) will be administered as: Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day, Lugol's solution 20 drops orally 3-times-a-day, OR KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab

Primary Outcome Measure Information:

Title

Complete Response (CR) Rate

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Description

ORR is assessed as the sum of the overall rates of CR confirmed by positron emission tomography (PET) CR not confirmed by PET, and Partial response (PR) negative for progression by PET

Time Frame

12 weeks

Title

Time-to-Progression (TTP)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA Histologically confirmed low grade CD20+ B cell non-Hodgkin lymphoma (NHL) patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm. The patients must have failed at least one chemotherapy regimen No anticancer treatment for three weeks prior to study initiation (six 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 Expected survival of at least 6 months Prestudy Performance Status of 0, 1 or 2 according to the World Health Organization (WHO) Absolute neutrophil count (ANC) of at least 1,500/mm³ Platelet count at least 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 EXCLUSION CRITERIA Disease progression within 3 months of last chemotherapy Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue Platelet count less than 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 HIV or AIDS-related lymphoma Evidence of myelodysplasia on bone marrow biopsy Abnormal bone marrow cytogenetics Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow Patients who have received filgrastim Sargramostim therapy within 3 weeks prior to treatment 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 and/or sponsor, would compromise other protocol objectives Another primary malignancy (other than squamous cell and basal cell cancer of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate-specific antigen, PSA) for which the patients has not been disease free for at least 3 years Major surgery, other than diagnostic surgery within 4 weeks Pleural effusion Pregnant Lactating

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

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Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

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