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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

December 13, 2007
June 7, 2012
January 2002
September 2002   (final data collection date for primary outcome measure)
To characterize the safety profile of IDEC-114 and to define their duration and reversibility [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00575068 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
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)
Experimental: 1
Intervention: Drug: IDEC-114
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
November 2010
September 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00575068
114-20
No
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP