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

This study has been terminated.
(Low Accrual)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Susan Knox, Stanford University
ClinicalTrials.gov Identifier:
NCT00490490
First received: June 20, 2007
Last updated: February 9, 2017
Last verified: February 2017
June 20, 2007
February 9, 2017
January 2007
June 2011   (Final data collection date for primary outcome measure)
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
Percentage of patients with CR (CR or CRu/PR with PET negativity). [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00490490 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall Response Rate (CR + PR), irradiated Site-dependent functional CR (CR of CRu/PR with PET negativity), or PR rate. [ Time Frame: Following treatment ]
  • Duration of Response [ Time Frame: Following treatment ]
  • Toxicity associated with the addition of XRT to involved bulky sites of disease with concurrent Iodine I-131 Tositumomab therapy (Bexxar), Time to Progression (TTP), Overall Survival, HAMA incidence, Toxicity that triggers the stopping rule. [ Time Frame: During and following treatment ]
Not Provided
Not Provided
 
Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy
Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
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).
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
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Lymphoma, Non-Hodgkin
  • 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
Experimental: Tositumomab + XRT + KI
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
Interventions:
  • Drug: Bexxar (tositumomab)
  • Procedure: External beam radiotherapy (XRT)
  • Drug: Potassium Iodide (KI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
July 2013
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00490490
IRB-07479
97437 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LYMNHL0046 ( Other Identifier: OnCore )
Yes
Not Provided
Not Provided
Susan Knox, Stanford University
Stanford University
GlaxoSmithKline
Principal Investigator: Susan J Knox Stanford University
Stanford University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP