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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Non-Hodgkin
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Interferons
Interferon-gamma
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014