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

This study has been terminated.
(administrative reasons)
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00057447
First received: April 1, 2003
Last updated: October 30, 2007
Last verified: October 2007
  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 1
Phase 2

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:


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:
    Drug: Interferon Gamma-1b
    100 or 200 mcg, SQ, 3x per week
    Drug: Rituximab
    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
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 April 16, 2014