Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00575068
First received: December 13, 2007
Last updated: June 7, 2012
Last verified: January 2011
  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 1
Phase 2

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: A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To characterize the safety profile of IDEC-114 and to define their duration and reversibility [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate PK [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • To monitor presence of human anti galiximab antibody [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • To evaluate efficacy [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • To identify Nk functional assays that may predict galiximab efficacy [ Time Frame: March 2010 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: January 2002
Study Completion Date: November 2010
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: IDEC-114
Phase 1-A Group 1 - 125 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 2 - 250 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 3 - 375 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-B Group 4 - 500 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase II-A & II-B - Dosage start at the MTD (up to 375 mg/m2)

  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
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: NCT00575068

Locations
United States, Arizona
Research Site
Tucson, Arizona, United States, 85724
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55902
United States, New York
Research Site
Buffalo, New York, United States, 14263
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00575068     History of Changes
Other Study ID Numbers: 114-20
Study First Received: December 13, 2007
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014