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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575068
• Other study ID #: 114-20
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 13, 2007
• Last updated: June 7, 2012
• Start date: January 2002
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2010
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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)

Locations

Country	Name	City	State
United States	Research Site	Buffalo	New York
United States	Research Site	Durham	North Carolina
United States	Research Site	Rochester	Minnesota
United States	Research Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the safety profile of IDEC-114 and to define their duration and reversibility		March 2010	Yes
Secondary	To evaluate PK		March 2010	No
Secondary	To monitor presence of human anti galiximab antibody		March 2010	No
Secondary	To evaluate efficacy		March 2010	No
Secondary	To identify Nk functional assays that may predict galiximab efficacy		March 2010	No