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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: IDEC-114

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Research Site
  • New York
    • Buffalo, New York, United States, 14263
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To characterize the safety profile of IDEC-114 and to define their duration and reversibility	March 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate PK	March 2010
To evaluate efficacy	March 2010
To monitor presence of human anti galiximab antibody	March 2010
To identify Nk functional assays that may predict galiximab efficacy	March 2010

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): September 1, 2002
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimate): December 17, 2007

Study Record Updates

• Last Update Posted (Estimate): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 7, 2012
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Anti-Inflammatory Agents; Antineoplastic Agents; Galiximab
• Other Study ID Numbers: 114-20