Clinical trial NCT00048555: Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma
Official title: A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® 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: 2002-11-05
Enrollment: 90
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: To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® \[Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL\], has in this patient population.


Eligibility criteria: Inclusion Criteria:

* Signed IRB-approved informed consent
* Greater than or equal to 18 years of age
* Proof of follicular lymphoma
* Progressive disease requiring treatment after at least 1 prior standard therapy
* Acceptable hematologic status, liver function, and renal function
* Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment

Exclusion Criteria:

* No response to prior Rituxan® or Rituxan®-containing regimen
* Presence of CLL or CNS lymphoma
* Known history of HIV infection or AIDS
* Prior diagnosis of aggressive NHL or mantle-cell lymphoma
* Serious nonmalignant disease
* Pregnant or currently breast feeding

Primary outcomes:
measure: To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
timeFrame: March 2010
Secondary outcomes:
measure: To evaluate PK
timeFrame: March 2010
measure: To evaluate efficacy
timeFrame: March 2010
measure: To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation
timeFrame: March 2010
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research site
state: Alabama
city: Tucson
country: United States
facility: Research site
state: Arizona
city: Los Angeles
country: United States
facility: Research site
state: California
city: Newport Beach
country: United States
facility: Research site
state: California
city: San Diego
country: United States
facility: Research site
state: California
city: Aurora
country: United States
facility: Research site
state: Colorado
city: Washington
country: United States
facility: Research site
state: District of Columbia
city: Tampa Bay
country: United States
facility: Research site
state: Florida
city: Chicago
country: United States
facility: Research site
state: Illinois
city: Maywood
country: United States
facility: Research site
state: Illinois
city: Boston
country: United States
facility: Research site
state: Massachusetts
city: Detroit,
country: United States
facility: Research site
state: Michigan
city: Rochester
country: United States
facility: Research site
state: Minnesota
city: Omaha
country: United States
facility: Research site
state: Nebraska
city: Buffalo
country: United States
facility: Research site
state: New York
city: New York
country: United States
facility: Research site
state: New York
city: Rochester
country: United States
facility: Research site
state: New York
city: Durham
country: United States
facility: Research site
state: North Carolina
city: Philadelphia
country: United States
facility: Research site
state: Pennsylvania
city: Columbia
country: United States
facility: Research site
state: South Carolina
city: Houston
country: United States
facility: Research site
state: Texas
city: Charlottesville
country: United States
facility: Research site
state: Virginia
Study officials:
References:
citation: Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216-23. doi: 10.1093/annonc/mdm114. Epub 2007 Apr 29.