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

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT00575068

Collaborator

(none)

Enrollment

Locations

Arm

106

Duration (Months)

10.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: IDEC-114	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Sep 1, 2002

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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)

Arm

Intervention/Treatment

Experimental: 1

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)

Outcome Measures

Primary Outcome Measures

To characterize the safety profile of IDEC-114 and to define their duration and reversibility [March 2010]

Secondary Outcome Measures

To evaluate PK [March 2010]
To monitor presence of human anti galiximab antibody [March 2010]
To evaluate efficacy [March 2010]
To identify Nk functional assays that may predict galiximab efficacy [March 2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Tucson	Arizona	United States	85724
2	Research Site	Rochester	Minnesota	United States	55902
3	Research Site	Buffalo	New York	United States	14263
4	Research Site	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00575068

Other Study ID Numbers:

114-20

First Posted:

Dec 17, 2007

Last Update Posted:

Jun 8, 2012

Last Verified:

Jan 1, 2011

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Galiximab

Study Results

No Results Posted as of Jun 8, 2012