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Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsored by: University of Nebraska
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004874
  Purpose

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Radiation: tositumomab and iodine I 131 tositumomab
Phase III

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

Study Start Date: November 1998
Detailed Description:

OBJECTIVES: I. Determine the efficacy and safety of iodine I 131 monoclonal antibody anti-B1 in patients with relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma.

OUTLINE: On day 1, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1. Patients receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 30 minutes on day 8. Patients are followed at weeks 13 and 25 and then every 6 months for up to 2 years.

PROJECTED ACCRUAL: Not specified

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma including the following: Small lymphocytic Follicular small cleaved cell Follicular mixed small cleaved and large cell (less than 50% large cell component) Tumor must be positive for CD20 antigen Relapse or disease progression following at least 1 chemotherapy regimen or failure to achieve an objective response (complete or partial response) on prior chemotherapy regimen No disease progression, within 1 year of irradiation, arising in a field previously irradiated with more than 3500 cGy Mean of no greater than 25% intratrabecular marrow space involved with lymphoma on bilateral iliac crest bone marrow biopsy A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.

However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 19 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST less than 5 times ULN Renal: Creatinine less than 1.5 times ULN No active obstructive hydronephrosis Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infection requiring IV antibiotics No other concurrent illness that would preclude evaluation No prior malignancy within the past 5 years except adequately treated skin cancer, carcinoma in situ of the cervix, or lymphoma HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No prior allergic reaction to iodine other than IV iodine containing contrast materials Human antimouse antibody negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy or cytokine treatment and recovered No prior hematologic stem cell transplantation Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radioimmunotherapy Surgery: Not specified Other: No concurrent IV antibiotics

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004874

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
Sponsors and Collaborators
University of Nebraska
Investigators
Study Chair: Julie M. Vose, MD University of Nebraska
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067534, UNMC-259-98, COULTER-CP-98-020
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004874     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent small lymphocytic lymphoma

Study placed in the following topic categories:
Immunoproliferative Disorders
Immunologic Factors
Iodine-131 anti-B1 antibody
Lymphoma, Follicular
Trace Elements
Follicular Lymphoma
Recurrence
Antibodies, Monoclonal
Lymphoma, Small Cleaved-cell, Diffuse
Anti-Infective Agents, Local
Lymphatic Diseases
Antibodies
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Iodine
Micronutrients
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Lymphoma
Immunoglobulins

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

ClinicalTrials.gov processed this record on July 02, 2009