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

This study has been terminated.

( administrative reasons )

First Received on April 1, 2003. Last Updated on 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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 Gamma Rays 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

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

Keywords provided by InterMune:

lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Interferon-gamma
Interferon-gamma, Recombinant

Interferons
Rituximab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012