Non-Hodgkin's Lymphoma
Conditions
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.
Interventions
DRUGIDEC-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)
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the safety profile of IDEC-114 and to define their duration and reversibility | March 2010 |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed