Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for the Retreatment of Patients With Non-Hodgkin's Lymphoma
NCT ID: NCT00022893
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Iodine-131 Anti-B1 Antibody
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Corixa Corporation
INDUSTRY
Locations
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Stanford University Medical Center
Palo Alto, California, United States
Rush Medical Center
Chicago, Illinois, United States
University of Michigan Cancer & Geriatric Center
Ann Arbor, Michigan, United States
Cornell Medical Center
New York, New York, United States
Christie Hospital NHS Trust
Manchester, , United Kingdom
Countries
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Other Identifiers
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CP-98-021
Identifier Type: -
Identifier Source: org_study_id