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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: IDEC-114


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: IDEC-114<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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