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Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Corixa Corporation
GlaxoSmithKline
Information provided by: Corixa Corporation
ClinicalTrials.gov Identifier: NCT00022880
  Purpose

The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody, to see what effects it has on patients with CLL and to determine the highest dose of Iodine-131 Anti-B1 Antibody that can be given without causing severe side effects.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Iodine-131 Anti-B1 Antibody
Phase I

MedlinePlus related topics:   Leukemia, Adult Acute    Leukemia, Adult Chronic   

Drug Information available for:   Iodine    Cadexomer iodine    Sodium iodide I 131    Tositumomab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase I, Dose-Escalation, Open-Label, Multicenter Study of Iodine-131, Anti-B1 Antibody for Intermediate- and High-Risk B-Cell Chronic Lymphocytic Leukemia

Further study details as provided by Corixa Corporation:

Estimated Enrollment:   30
Study Start Date:   July 1999

Detailed Description:

The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti-B1 Antibody in patients with CLL. Secondary endpoints include assessment of response rate, duration of response, relapse free survival, time to treatment failure, safety, and survival.

The dose escalation will be started at 35cGy for patients with platelet counts > 100,000 cells/mm3 (Cohort A) and increased by groups in 10cGy increments until the maximum tolerated dose (MTD) is reached. Subsequently, patients with platelet counts from 75,000-100,000 cells/mm3 (Cohort B) will be enrolled starting at 10cGy below the MTD reached in Cohort A and the dose will be escalated in 10cGy increments up to the MTD.

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

Criteria

Inclusion Criteria:

  • Patients must fulfill the criteria for the diagnosis of intermediate-risk B-cell CLL or high-risk B-cell CLL
  • The bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.
  • Patients must have evidence that their leukemic lymphocytes express the CD20 antigen.
  • Patients must have been previously treated with chemotherapy or biologic therapy and have progressed on, failed to achieve an objective response (CR or partial response [PR]) on, or progressed after completion of last therapy. Patients must have received at least one therapy containing a purine nucleoside analogue. Patients must not have received more than 4 prior therapies. This includes both chemotherapy and biologic therapy.
  • Patients must have an absolute granulocyte count >500 cells/mm3 and a platelet count of either >100,000 cells/mm3 (Cohort A) or a platelet count of 75,000-100,000 cells/mm3 deemed to be secondary to CLL by the investigator, (Cohort B) within 14 days of study entry. These blood counts must be sustained for 4 weeks without support of hematopoietic cytokines or transfusion of blood products.
  • Patients must have a Karnofsky Performance status of at least 60% and an anticipated survival of at least 3 months.
  • Patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal [ULN]) and hepatic function (defined as total bilirubin <1.5 x ULN and AST <3 x ULN) within 14 days of study entry. For patients with autoimmune hemolytic anemia, the bilirubin must be less than or equal to 8 x ULN.

Exclusion Criteria:

  • Patients who have received prior therapy with cytotoxic chemotherapy or immunosuppressants (with the exception of maintenance prednisone therapy not to exceed a dose of 20 mg/day for autoimmune hemolysis only) within FOUR weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The prednisone must have been started more than 4 weeks prior to study entry.
  • Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cGy.
  • Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
  • Patients with active obstructive hydronephrosis.
  • Patients with prior malignancy other than CLL, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. Patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
  • Patients with known HIV infection.
  • Patients who are pregnant or nursing. Patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving Iodine-131 Anti-B1 Antibody.
  • Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
  • Patients with evidence of active infection requiring intravenous treatment with anti-infectives.
  • Patients known to be HAMA positive.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022880

Locations
United States, California
Stanford University Medical Center    
      Palo Alto, California, United States, 94305
United States, New York
Long Island Jewish Medical Center    
      New Hyde Park, New York, United States, 11041

Sponsors and Collaborators
Corixa Corporation
GlaxoSmithKline
  More Information


Study ID Numbers:   CP-98-018
First Received:   August 15, 2001
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00022880
Health Authority:   United States: Food and Drug Administration

Keywords provided by Corixa Corporation:
Chronic Lymphocytic Leukemia  
Dose-Escalation  
Radioimmunotherapy  
Monoclonal Antibody  
Corixa  
Bexxar
Anti-B1 Antibody
Tositumomab
Iodine -131 Anti-B1 Antibody
Iodine I 131 Tositumomab

Study placed in the following topic categories:
Antibodies, Monoclonal
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Antibodies
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Iodine-131 anti-B1 antibody
Iodine
Lymphoproliferative Disorders
Leukemia, B-Cell

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 December 03, 2008




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