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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Galiximab

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