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Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by Stanford University, July 2008
First Received: June 20, 2007   Last Updated: July 22, 2008   History of Changes
Sponsors and Collaborators: Stanford University
GlaxoSmithKline
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00490490
  Purpose

We hope to learn whether I-131 tositumomab combined with external beam radiation therapy is an effective means of treating relapsed, bulky non-Hodgkin's lymphoma. The purpose of the study is to determine the overall response rate with responses described as: Site-dependent and overall CR and functional CR (CR of CRu/PR with PET negativity), or PR rates.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: Tositumomab and iodine I 131 tositumomab
Procedure: External beam radiotherapy
Phase II

MedlinePlus related topics: Lymphoma Radiation Therapy
Drug Information available for: Cadexomer iodine Tositumomab Iodine Sodium iodide I 131
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percentage of patients with CR (CR or CRu/PR with PET negativity).

Secondary Outcome Measures:
  • Overall Response Rate (CR + PR), irradiated Site-dependent functional CR (CR of CRu/PR with PET negativity), or PR rate.
  • Duration of Response
  • 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

Estimated Enrollment: 25
Study Start Date: January 2007
Detailed Description:

At the present time over 1,600 patients have been treated with iodine I 131 tositumomab (Bexxar) in a variety of clinical trials. The overall clinical data demonstrate that patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma derive significant therapeutic benefit from iodine I 131 tositumomab. Data describing its safety and efficacy are available for over 700 patients. In aggregate, the data demonstrate that iodine I 131 tositumomab produces: 1) high overall and complete response rates, 2) clinically meaningful prolongations of response compared to those achieved after patients last prior therapies, 3) durable complete responses, and 4) manageable toxicity in patients with low grade or transformed non-Hodgkin's lymphoma. The purpose of this study is to study the safety and efficacy of this treatment in combination with external beam radiation in patients with relapsed bulky NHL.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Histologically confirmed low grade CD20+ B cell 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), and fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
  • An IRB approved signed informed consent
  • Age greater and or equal to 19 years
  • Expected survival of at least 6 months
  • Prestudy Performance Status of 0, 1 or 2 according to the WHO
  • Acceptable laboratory status within 2 weeks prior to patient enrollment including:

    • ANC of at least 1,500/mm^3, platelet count at least 100,000/mm3, Hct greater than 30% and Hgb greater than 9.0 gm
    • Bilirubin less than or equal to 2.0, Creatinine less than or equal to 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 of reproductive potential
  • Female patients who are not pregnant or lactating Exclusion Criteria:- Disease progression within 3 months of last chemotherapy
  • Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
  • Patients with impaired bone marrow reserve as indicated by one or more of the following:

    • Platelet count less than 100,000/mm^3
    • Hypocellular bone marrow (less than or equal to 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 CNS lymphoma
  • Patients with HIV or AIDS-related lymphoma
  • Patients with evidence of myelodysplasia on bone marrow biopsy or 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 G-CSF or GM-CSF therapy within 3 weeks prior to treatment
  • Pregnant or lactating women
  • Presence of 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 CA of the skin, in situ CA of the cervix, or treated prostate cancer with stable PSA) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490490

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Dana Peralta     650-725-1730     pdawn07@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Susan J Knox            
Sub-Investigator: Ranjana Hira Advani            
Sub-Investigator: Kristen N. Ganjoo            
Sub-Investigator: Michael L Goris            
Sub-Investigator: Richard T. Hoppe            
Sub-Investigator: Ronald Levy            
Sponsors and Collaborators
Stanford University
GlaxoSmithKline
Investigators
Principal Investigator: Susan J Knox Stanford University
  More Information

No publications provided

Study ID Numbers: LYMNHL0046, 97437, NCT00490490
Study First Received: June 20, 2007
Last Updated: July 22, 2008
ClinicalTrials.gov Identifier: NCT00490490     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Immunologic Factors
Iodine-131 anti-B1 antibody
Iodine
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Iodine-131 anti-B1 antibody
Pharmacologic Actions
Antibodies, Monoclonal
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009