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