Back to resultsSafety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IDEC-114
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To characterize the safety profile of IDEC-114 and to define their duration and reversibility
Secondary Outcome Measures
To evaluate PK
To monitor presence of human anti galiximab antibody
To evaluate efficacy
To identify Nk functional assays that may predict galiximab efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00575068
Brief Title
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
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IDEC-114
Intervention Description
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)
Primary Outcome Measure Information:
Title
To characterize the safety profile of IDEC-114 and to define their duration and reversibility
Time Frame
March 2010
Secondary Outcome Measure Information:
Title
To evaluate PK
Time Frame
March 2010
Title
To monitor presence of human anti galiximab antibody
Time Frame
March 2010
Title
To evaluate efficacy
Time Frame
March 2010
Title
To identify Nk functional assays that may predict galiximab efficacy
Time Frame
March 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
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