Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
Phase 1
Completed
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Drug: IDEC-114
- Registration Number
- NCT00575068
- Lead Sponsor
- Biogen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 IDEC-114 -
- Primary Outcome Measures
Name Time Method To characterize the safety profile of IDEC-114 and to define their duration and reversibility March 2010
- Secondary Outcome Measures
Name Time Method 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 To evaluate PK March 2010
Trial Locations
- Locations (1)
Research Site
🇺🇸Durham, North Carolina, United States