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

This study has been terminated.
(Low Accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490490
First Posted: June 22, 2007
Last Update Posted: March 29, 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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Susan Knox, Stanford University
  Purpose
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).

Condition Intervention Phase
Lymphoma, Non-Hodgkin Drug: Bexxar (tositumomab) Procedure: External beam radiotherapy (XRT) Drug: Potassium Iodide (KI) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Complete Response (CR) Rate [ Time Frame: 12 weeks ]

    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) [ Time Frame: 12 weeks ]

    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) [ Time Frame: 2 years ]

Enrollment: 8
Study Start Date: January 2007
Study Completion Date: July 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tositumomab + XRT + KI
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
Drug: Bexxar (tositumomab)
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.
Other Name: 131-iodine tositumomab
Procedure: External beam radiotherapy (XRT)
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.
Other Name: Radiotherapy (RT)
Drug: Potassium Iodide (KI)

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
Other Names:
  • Saturated Solution Potassium Iodide (SSKI)
  • Lugol's solution
  • Potassium iodide tablets

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490490


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

Responsible Party: Susan Knox, Associate Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT00490490     History of Changes
Other Study ID Numbers: IRB-07479
97437 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LYMNHL0046 ( Other Identifier: OnCore )
First Submitted: June 20, 2007
First Posted: June 22, 2007
Results First Submitted: December 19, 2016
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pharmaceutical Solutions
Iodine
Iodine-131 anti-B1 antibody
Lugol's solution
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Hemostatics
Coagulants