Expanded Access Study of Iodine-131 Anti-B1 Antibody

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:
NCT00022958
First received: August 16, 2001
Last updated: June 23, 2005
Last verified: August 2004
  Purpose

The primary objective of this study is to make Iodine-131 Anti-B1 Antibody more broadly available to patients. Secondary endpoints of the study will be to obtain additional information on the efficacy and safety of Iodine-131 Anti-B1 Antibody.


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: Expanded Access Study of Iodine-131 Anti-B1 Antibody for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Corixa Corporation:

Study Start Date: September 1998
  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 diagnosis of low-grade NHL or transformed low-grade NHL according to International Working Formulation for Clinical Usage. (The following low-grade histologies are to be included: small lymphocytic; follicular, small cleaved; and follicular, mixed small-cleaved and large cell [<50% large cell component]). Tumor must be positive for CD20 antigen.
  • Patients must have been treated with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response (CR or PR) on their last chemotherapy regimen.
  • Patients must have a Karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
  • Patients must have an absolute granulocyte count greater than or equal to 1,500/mm3, a platelet count greater than or equal to 100,000/mm3, and not require sustained support of hematopoietic cytokines or transfusion of blood products.
  • Patients must have adequate renal function (defined as serum creatinine <1.5 times upper limit of normal), hepatic function (defined as total bilirubin <1.5 times upper limit of normal), and hepatic transaminases (defined as AST <5 times upper limit of normal).

EXCLUSION CRITERIA:

  • Patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma on bilateral iliac crest bone marrow biopsy. Patients with a <10% lymphoma involvement on unilateral biopsy do not require bilateral biopsy.
  • Patients who have received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. Patients who have received systemic steroids within 1 week of study entry are excluded, except patients on maintenance steroid therapy for a non-cancerous disease.
  • Patients who have undergone treatment with either stem cell or bone marrow transplant.
  • 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 known HIV infection.
  • Patients who are pregnant or nursing. Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving Iodine-131 Anti-B1 Antibody.
  • Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer (basal cell or squamous cell carcinoma), 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 progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cGy.
  • Patients who previously received radioimmunotherapy.
  • Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
  • Patients with known brain or leptomeningeal metastases.
  • Patients who are HAMA positive.
  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: NCT00022958

Locations
United States, California
Central Recruiting Information
South San Francisco, California, United States
Sponsors and Collaborators
Corixa Corporation
GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00022958     History of Changes
Other Study ID Numbers: CP-98-020
Study First Received: August 16, 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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Iodine
Iodine-131 anti-B1 antibody
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents
Growth Substances
Immunologic Factors
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 29, 2014