Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
NCT ID: NCT00575068
Last Updated: 2012-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2002-01-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Locations
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Research Site
Tucson, Arizona, United States
Research Site
Rochester, Minnesota, United States
Research Site
Buffalo, New York, United States
Research Site
Durham, North Carolina, United States
Countries
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Other Identifiers
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114-20
Identifier Type: -
Identifier Source: org_study_id
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