Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients

This study has been terminated.

( administrative reasons )

First Received: April 1, 2003 Last Updated: October 30, 2007 History of Changes

Sponsor:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00057447

Purpose

Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)

International study with sites in the Czech Republic and Poland

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: Interferon Gamma-1b Drug: Rituximab	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of the Safety of Subcutaneous Interferon Gamma-1b Combined With Rituximab in Patients With Low Grade/Follicular Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Interferon gamma-1b Rituximab Interferons

U.S. FDA Resources

Further study details as provided by InterMune:

Primary Outcome Measures:

time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes) [ Time Frame: 6 weeks ]

Enrollment:	24
Study Start Date:	March 2003
Study Completion Date:	June 2004

Intervention Details:

100 or 200 mcg, SQ, 3x per week

375 mg per square meters, IV, 1x per week

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Relapsed or progressive low-grade/follicular NHL who are candidates for rituximab therapy
Patients who were on other therapy including CHOP or radiation
Previous therapy must have concluded 30 days prior to enrollment
Demonstrable CD20-positive tumor population in lymph nodes or bone marrow

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057447

Locations

United States, California
Intermune Inc
Brisbane, California, United States, 94005

Sponsors and Collaborators

InterMune

Investigators

Study Director:

Williamson Bradford, MD

InterMune

More Information

No publications provided

Study ID Numbers:	GINHL-001
Study First Received:	April 1, 2003
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00057447 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by InterMune:

lymphoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Interferon Type II
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Interferons
Lymphoma, Follicular

Antiviral Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on February 08, 2010