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Study of Untreated or Transformed Follicular Non-Hodgkin's Lymphoma With Fission-Derived Iodine I 131 Tositumomab

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00062894
  Purpose

The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Iodine I 131 Tositumomab
Phase I
Phase II

MedlinePlus related topics:   Lymphoma   

ChemIDplus related topics:   Iodine    Cadexomer iodine    Sodium iodide I 131    Tositumomab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:   A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma

Secondary Outcome Measures:
  • 12 patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma will receive a dosimetric dose of fission-derived Iodine I 131 Tositumomab

Enrollment:   12
Study Start Date:   April 2003
Estimated Study Completion Date:   April 2007

Detailed Description:

This is a multi-center study in which 12 patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma will receive a dosimetric dose of fission-derived Iodine I 131 Tositumomab followed by a therapeutic dose of tellurium-derived Iodine I 131 Tositumomab. Blood Pharmacokinetics, total body clearance, tumor and organ dosimetry, and biodistribution will be assessed following administration of the dosimetric dose.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma (WHO/REAL classification).

Follicular, small cleaved; Follicular, mixed small cleaved and large cell; Follicular large cell lymphoma Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.

  • Stage III or IV disease at the time of study entry.
  • Previously untreated or recurrent lymphoma after no more than four prior qualifying therapy regimens.
  • Performance status of at least 70% on the Karnofsky Performance Scale and an anticipated survival of at least three months.
  • Bi-dimensionally measurable disease with at least one lesion measuring greater than or equal to 2.0 cm x 2.0 cm (=4.0 cm2)by CT scan.
  • Absolute B lymphocyte count (as determined by CD 19 reactivity)of 30 to 350 cell/mm3 within 21 days prior to study enrollment.
  • ANC greater than or equal to 1500 cells/mm3; absolute lymphocyte count within normal limits; and platelet count greater than or equal to 150,000/mm3 within 21 days prior to study enrollment. Blood products and/or growth factors should not have been taken within 4 weeks prior to blood draw.
  • Adequate renal function (defined as serum creatinine < 1.5 x ULN) and hepatic function (defined as total bilirubin < 1.5 x ULN and AST < 5 x ULN) within 21 days of study enrollment.
  • Human Anti-Murine Antibody (HAMA) negative within 21 days prior to study enrollment.
  • Signed IRB approved consent form prior to any study-specific procedures being implemented.

Exclusion Criteria:

  • Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days of study enrollment. Bilateral posterior iliac crest core biopsies are required if the core obtained on a unilateral biopsy is less than 2 cm.
  • Prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for their NHL within 28 days prior to study enrollment.
  • Prior Rituximab therapy within 120 days prior to study enrollment.
  • Prior radioimmunotherapy.
  • Prior splenectomy.
  • Splenomegaly defined as spleen mass greater than 700 grams.
  • Bulky disease as defined as any unidimensional measurement of lymphomatous mass exceeding 7 cm.
  • Prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has a generally accepted risk of recurrence less than 20%.
  • Central nervous system involvement by lymphoma.
  • Evidence of active infection requiring IV antibiotics at the time of study enrollment.
  • Known HIV infection.
  • New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
  • Active obstructive hydronephrosis.
  • Evidence of clinically significant ascites or pleural effusion observed on screening physical exam or baseline CAT xcan.
  • Prior myeloablative therapy.
  • History of failed stem cell collection.
  • Pregnant or nursing patients. Patients of childbearing potential must undergo a serum pregnancy test within 7 days of study enrollment and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females of childbearing age, must agree to use effective contraception for six months following the radioimmunotherapy.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062894

Locations
United States, Florida
Bay Pines VA Medical Center    
      Bay Pines, Florida, United States, 33744
United States, Illinois
Rush Medical Center    
      Chicago, Illinois, United States, 60612
United States, Michigan
University of Michigan Medical Center    
      Ann Arbor, Michigan, United States, 48109-0936
United States, Nebraska
University of Nebraska Medical Center    
      Omaha, Nebraska, United States, 68198-7680
United States, North Carolina
Duke University Medical Center    
      Durham, North Carolina, United States, 27710
United States, Pennsylvania
Hospital of the University of Pennsylvania    
      Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information

Study ID Numbers:   CCBX001-048
First Received:   June 17, 2003
Last Updated:   September 13, 2007
ClinicalTrials.gov Identifier:   NCT00062894
Health Authority:   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Iodine I 131 Tositumomab  
BEXXAR  
non-Hodgkin's lymphoma  

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Iodine-131 anti-B1 antibody
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Iodine
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Trace Elements
Pharmacologic Actions
Anti-Infective Agents, Local
Neoplasms
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on September 05, 2008




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