Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for the Retreatment of Patients With Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2004 by Corixa Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Corixa Corporation
ClinicalTrials.gov Identifier:
NCT00022893
First received: August 15, 2001
Last updated: June 23, 2005
Last verified: August 2004
  Purpose

The purpose of this study is to enable retreatment with Iodine-131 Anti-B1 Antibody therapy for patients with non-Hodgkin's lymphoma (NHL) who previously responded (PR, CCR, or CR) for at least 3 months to Iodine-131 Anti-B1 Antibody therapy.


Condition Intervention
Non-Hodgkin's Lymphoma
Drug: Iodine-131 Anti-B1 Antibody

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti-B1 Antibody.

Resource links provided by NLM:


Further study details as provided by Corixa Corporation:

Detailed Description:

The endpoints of the study are to determine the response rate, complete response rate, duration of response, time to progression, time-to-treatment failure, safety, and survival following Iodine-131 Anti-B1 Antibody therapy in patients with NHL who previously responded (PR, CCR, or CR) with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy.

  Eligibility

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

Inclusion Criteria:

  • Patients must have a histologically confirmed initial diagnosis of non-Hodgkin's B-cell lymphoma.
  • Patients must have previously responded (PR, CCR, or CR) with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy. The patient's disease must have progressed following the response to Iodine-131 Anti-B1 Antibody therapy.
  • Patients must have evidence that their tumor tissue expresses the CD20 antigen.
  • Patients must have a performance status of at least 60% on the Karnofsky Scale and an anticipated survival of at least 3 months.
  • Patients must have an absolute granulocyte count (ANC)>1,500 cells/mm3 (US) or >1,500 x 109/l (UK) and a platelet count >100,000 cells/mm3 (US) or >100,000 x 109/l (UK) within 14 days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
  • Patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal) and hepatic function (defined as total bilirubin <1.5 x upper limit of normal and hepatic transaminases [AST and ALT] <5 x upper limit of normal) within 14 days of study entry.
  • Patients must have bi-dimensionally measurable disease. At least one lesion must be greater than or equal to 2 x 2 cm (by CT scan).

Exclusion Criteria:

  • Patients with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
  • Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids must be discontinued at least 1 week prior to study entry.
  • Patients with active obstructive hydronephrosis.
  • Patients with evidence of active infection requiring IV antibiotics at the time of study entry.
  • Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
  • Patients with prior malignancy other than lymphoma, 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 with known brain or leptomeningeal metastases.
  • Patients who are pregnant or nursing (breastfeeding). Patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. Males and females must agree to use effective contraception for 6 months following treatment.
  • Patients with previous allergic reactions to iodine. This does not include reacting to IV iodine-containing contrast materials.
  • Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cGy.
  • Patients who became HAMA positive following Iodine-131 Anti-B1 Antibody therapy or patients who are HAMA positive at the time of enrollment.
  • Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022893

Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
United States, Illinois
Rush Medical Center
Chicago, Illinois, United States, 60612
United States, Michigan
University of Michigan Cancer & Geriatric Center
Ann Arbor, Michigan, United States, 48109-0936
United States, New York
Cornell Medical Center
New York, New York, United States, 10021
United Kingdom
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Corixa Corporation
GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00022893     History of Changes
Other Study ID Numbers: CP-98-021
Study First Received: August 15, 2001
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Corixa Corporation:
Non-Hodgkin's Lymphoma
Radioimmunotherapy
Monoclonal Antibody
Corixa
Bexxar
Anti-B1 Antibody
Tositumomab
Iodine -131 Anti-B1 Antibody
Iodine I 131 Tositumomab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Iodine
Cadexomer iodine
Iodine-131 anti-B1 antibody
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Trace Elements
Micronutrients
Growth Substances
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014