Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma

This study has been completed.

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00575068

First received: December 13, 2007

Last updated: June 7, 2012

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 13, 2007
Last Updated Date	June 7, 2012
Start Date ^ICMJE	January 2002
Primary Completion Date	September 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 18, 2009)	To characterize the safety profile of IDEC-114 and to define their duration and reversibility [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00575068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 18, 2009)	To evaluate PK [ Time Frame: March 2010 ] [ Designated as safety issue: No ] To monitor presence of human anti galiximab antibody [ Time Frame: March 2010 ] [ Designated as safety issue: No ] To evaluate efficacy [ Time Frame: March 2010 ] [ Designated as safety issue: No ] To identify Nk functional assays that may predict galiximab efficacy [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
Official Title ^ICMJE	A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non-Hodgkin's Lymphoma
Intervention ^ICMJE	Drug: IDEC-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)
Study Arm (s)	Experimental: 1 Intervention: Drug: IDEC-114
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	42
Completion Date	November 2010
Primary Completion Date	September 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00575068
Other Study ID Numbers ^ICMJE	114-20
Has Data Monitoring Committee	No
Responsible Party	Biogen Idec MD, Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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