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Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
This study has been completed.
Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00575068
  Purpose

The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never been studied in patients with lymphoma, however, it has been studied in psoriasis patients at various dose levels and schedules.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: IDEC-114
Phase I
Phase II

MedlinePlus related topics: Lymphoma
Drug Information available for: Immunoglobulins Globulin, Immune Galiximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title: A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma

Further study details as provided by Biogen Idec:

Study Start Date: January 2002
Study Completion Date: December 2003
  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed follicular lymphoma that has relapsed or has failed primary therapy
  • Progressive disease requiring further treatment
  • Bidimensionally measurable disease
  • Acceptable hematologic status
  • Prestudy WHO performance status of 0, 1, or 2
  • Expected survival of >/= 3 months
  • Patients with reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment
  • Female patients must not be pregnant or lactating
  • Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, ABMT, or investigational drugs

Exclusion Criteria:

  • Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first scheduled treatment (6 weeks if nitrosourea or mitomycin-C)
  • Prednisone or other immunosuppressive therapy within 3 weeks of first scheduled treatment
  • Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to first scheduled treatment
  • Previous exposure to IDEC-114 or any anti-CD80 antibody
  • ABMT within 6 months prior to first scheduled treatment
  • Abnormal liver function
  • Abnormal renal function
  • Presence of chronic lymphocytic leukemia (CLL)
  • Presence of CNS lymphoma
  • Presence of HIV infection or AIDS
  • Prior diagnosis of aggressive non-Hodgkin's lymphoma or mantle-cell lymphoma
  • Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years
  • Serious nonmalignant disease which would compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to first scheduled treatment
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled treatment
  • Pleural invasion and/or effusion with positive cytology for lymphoma
  • Peritoneal invasion and/or ascites with positive cytology for lymphoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575068

Locations
United States, Arizona
Arizona Cancer Center/University of Arizona
Tucson, Arizona, United States, 85724
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New York
Roswell Park Cancer Institute, Department of Medicine
Buffalo, New York, United States, 14263
United States, North Carolina
Duke University Medical Center, Morris Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Biogen Idec Biogen Idec
  More Information

Responsible Party: Biogen Idec ( Biogen Idec MD )
Study ID Numbers: 114-20
Study First Received: December 13, 2007
Last Updated: December 13, 2007
ClinicalTrials.gov Identifier: NCT00575068  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009