Clinical trial NCT00575068: Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
Official title: A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To characterize the safety profile of IDEC-114 and to define their duration and reversibility
timeFrame: March 2010
Secondary outcomes:
measure: To evaluate PK
timeFrame: March 2010
measure: To monitor presence of human anti galiximab antibody
timeFrame: March 2010
measure: To evaluate efficacy
timeFrame: March 2010
measure: To identify Nk functional assays that may predict galiximab efficacy
timeFrame: March 2010
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
Study officials:
References: