Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

This study has been terminated.
(lack of FDA approval)
Sponsor:
Collaborators:
Coulter Pharmaceuticals, Inc
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00004874
First received: March 7, 2000
Last updated: April 17, 2013
Last verified: April 2013
  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 3

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 University of Nebraska:

Primary Outcome Measures:
  • Expanded Access [ Time Frame: Study completion ] [ Designated as safety issue: No ]
    The primary objective of this stud is to make Iodin-131 Anti-B1 Antibody more broadly available to patients


Secondary Outcome Measures:
  • Safety [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
    Secondary endpoints of the study will be to obtain additional information on the safety of Iodine-131 Anti-B1 Antibody

  • efficacy [ Time Frame: study completion ] [ Designated as safety issue: No ]
    Secondary endpoints of the study will be to obtain additional information on the efficacy of Iodine-131 Anti-B1 Antibody


Enrollment: 31
Study Start Date: November 1998
Study Completion Date: November 2012
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: tositumomab and iodine I 131 tositumomab
    Dosimetric Dose:Unlabeled anti-B1 (450mg) will be given as peripheral or central IV infusion over one hour or longer depending upon rate-dependent side effects. A trace-labeled dose of 131I-anti-B will be infused over 20 minutes, if rate-dependent side effects permit. An amount of unlabeled Anti-B1 Antibody is added to the 5 mCi of Iodine-131 Anti-B1 Antibody sufficient to result in a final amount of 35 mg of Anti-B1 antibody. On study Day 7 (may be delayed up to study Day 14), patients will receive the therapeutic dose, which consists of an infusion of 450mg of Anti-B1 Antibody followed by an infusion of Iodine-131 Anti-B1 Antibody.
    Other Name: Iodine-131 Anti-B1 Antibody
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: Expanded Access Trial, no maximum accrual

  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
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: NCT00004874

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

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT00004874     History of Changes
Other Study ID Numbers: 259-98, P30CA036727, UNMC-259-98, COULTER-CP-98-020
Study First Received: March 7, 2000
Last Updated: April 17, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of Nebraska:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent small lymphocytic lymphoma

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 August 28, 2014