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

Completed · Phase 1/Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00575068

Run by

Biogen

People needed

42

Starts

2002-01-01

Expected to finish

2010-11-01

Last updated by the study team

2012-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Buffalo, New York, United States
• Research Site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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